Harleco
Medical device manufacturer in Mchenry, IL.
116510(k) clearances
0PMA approvals
0recalls
Device types
- CGX Alkaline Picrate, Colorimetry, Creatinine 8
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 6
- CIG Diazo Colorimetry, Bilirubin 6
- CEK Biuret (Colorimetric), Total Protein 6
- CFR Hexokinase, Glucose 6
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 5
- CEO Phosphomolybdate (Colorimetric), Inorganic… 5
- CIX Bromcresol Green Dye-Binding, Albumin 5
- JMK Acid, Alpha-Ketobutyric And Nadh (U.V.)… 4
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 4
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 4
- CIJ Saccharogenic, Amylase 4
- CJY Azo Dye, Calcium 4
- JFJ Catalytic Methods, Amylase 3
- LFR Glucose Dehydrogenase, Glucose 3
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 3
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 3
- JHW U.V. Method, Cpk Isoenzymes 3
- CGA Glucose Oxidase, Glucose 3
- JQB Kinetic Method, Gamma-Glutamyl Transpeptidase 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
| K812593 | Ultra Zyme Plus CK-1 #64978, 65027 & 28CGS · Traditional | 10/02/1981SE |
| K812596 | Ultra Zyme Plus Alp #64962, 65029 & 30CJE · Traditional | 09/29/1981SE |
| K812595 | Ultra Chem E-Glu #64976 & 65040CFR · Traditional | 09/29/1981SE |
| K812592 | Ultra Zyme Plus Got #64953, 65033 & 34CIT · Traditional | 09/24/1981SE |
| K812591 | Ultra Zyme Plus GPT, #64956, 65035 & 36CKA · Traditional | 09/24/1981SE |
| K812590 | Ultra Zyme Plus LDH #64950, 65038 & 39CFJ · Traditional | 09/24/1981SE |
| K812589 | Ultra Chem E-Trig #65024CDT · Traditional | 09/24/1981SE |
| K812500 | Ultrachem Uric Acid Aldh, Item #65047CDO · Traditional | 09/23/1981SE |
| K812258 | Acr Enzymatic Glucose OxidaseCGA · Traditional | 08/31/1981SE |
| K811576 | Cardiozyme Plus Ck-Total Item #65046 (a)CGS · Traditional | 06/25/1981SE |
| K811575 | Cardiozyme Plus Ck-Mb Item #65045 (G)JHW · Traditional | 06/25/1981SE |
| K811574 | Cardiozyme Plus Ck-Total Item #65046CGS · Traditional | 06/25/1981SE |
| K811573 | Cardiozyme Plus Ck-Mb Item #65045JHW · Traditional | 06/25/1981SE |
| K811202 | Ultrachem Gluc-Dh, Item No. 65048LFR · Traditional | 05/27/1981SE |
| K810684 | Hemocolor Stain SetICC · Traditional | 04/08/1981SE |
| K810725 | Qualitrol #65057JJT · Traditional | 03/31/1981SE |
| K803169 | Cardiozyme Plus Ck-Total #65046JHS · Traditional | 01/09/1981SE |
| K803168 | Cardio Zyme Plus Ck-Mb #65045JHW · Traditional | 01/09/1981SE |
| K780829 | Sysing and Hemoglobin ReagentGKR · Traditional | 06/22/1978SE |
| K780830 | Isotonic Buffered SalineGIF · Traditional | 06/14/1978SE |
| K780524 | Ultrachem T-Bili 64971 Gilford 3500CIG · Traditional | 05/19/1978SE |
| K780523 | Ultrachem Enzymatic Cholesterol 65025CHH · Traditional | 05/19/1978SE |
| K780515 | Ultrachem E-Glu, 300 Series CentrifuchemCFR · Traditional | 05/19/1978SE |
| K780514 | Ultrachem Creatinine 64972, CentrifuchemCGX · Traditional | 05/19/1978SE |
| K780513 | Ultra Zyme Plus Amyl 64982, Gilford 3500CIJ · Traditional | 05/19/1978SE |
| K780172 | Triglyceride Instrument ApplicationCDT · Traditional | 03/09/1978SE |
| K780141 | Ultrazyme Plus Amyl, Centrifichem Appli.CIJ · Traditional | 03/09/1978SE |
| K780100 | Ultrazyme Plus CK-1CGS · Traditional | 03/09/1978SE |
| K780099 | Ultrazyme Plus GTJPZ · Traditional | 03/09/1978SE |
| K780101 | Ultrazyme Plus LDHCFJ · Traditional | 02/14/1978SE |
| K780104 | Ultrazyme Plus HBDJMK · Traditional | 02/13/1978SE |
| K780103 | Ultrazyme Plus GotCIT · Traditional | 02/13/1978SE |
| K780102 | Ultrazyme Plus GPTCKA · Traditional | 02/13/1978SE |
| K780095 | Ultrazyme Plus AlpCJE · Traditional | 02/13/1978SE |
| K780094 | Iron Binding Capacity ChemistryJMO · Traditional | 02/13/1978SE |
| K780093 | Glucose Reagent for Glucose AnalyzerCGA · Traditional | 02/13/1978SE |
| K780092 | Ultrachem AlbuminCIX · Traditional | 02/07/1978SE |
| K780065 | Ultrachem E-Glu, Manual Determ.CFR · Traditional | 02/01/1978SE |
| K772258 | Clinicard Ck-IiCGS · Traditional | 01/05/1978SE |
| K772157 | Creatinine, 64972CGX · Traditional | 12/06/1977SE |
| K772156 | Ultrachem Phosphorus, 64973CEO · Traditional | 12/06/1977SE |
| K772155 | Ultrachem Total Protein, #64974CEK · Traditional | 12/06/1977SE |
| K772107 | Creatinine Urine APPLI.-#32308CGX · Traditional | 11/28/1977SE |
| K772035 | Gemsaec Appli. for Ultrazyme Plus Y-AmylJFJ · Traditional | 11/17/1977SE |
| K772034 | Gemsaec Appli. for Ultrazyme Plus CK-1 · Traditional | 11/17/1977SE |
| K772033 | Gemsaec Appli. for Ultrazyme Plus Alp*JMK · Traditional | 11/17/1977SE |
| K772032 | Gemsaec Appli. for Ultrazyme Plus AlpCJE · Traditional | 11/17/1977SE |
| K772029 | Gemsaec Appli, for Ultrazyme Plus GotCIT · Traditional | 11/15/1977SE |
| K772028 | Gemsaec Appli. for Ultrazyme Plus LDHCFJ · Traditional | 11/15/1977SE |
| K772031 | Gemsaec Appli. for Ultrazyme Plus Y-Gt · Traditional | 11/14/1977SE |
| K772030 | Gemsaec Appli. for Ultrazyme Plus GPTCKA · Traditional | 11/14/1977SE |
| K771928 | Calcium Set, Item No. 65004CJY · Traditional | 11/14/1977SE |
| K771927 | Iron Set, Item No. 65008JMO · Traditional | 11/14/1977SE |
| K771926 | Total Protein Set, Item No. 64010CEK · Traditional | 11/11/1977SE |
| K771925 | Krystalonr Liq. Mounting Med.&CoverslipKES · Traditional | 11/02/1977SE |
| K771754 | Glucose Reagent for Gluc. AnalyzerCGA · Traditional | 10/18/1977SE |
| K771773 | Clinicard Creatinine ChemistryCGX · Traditional | 10/14/1977SE |
| K771389 | CK-1 Ultrazyme PlusCGS · Traditional | 09/02/1977SE |
| K771388 | Amylase Ultrazyme PlusJFJ · Traditional | 09/02/1977SE |
| K771524 | Histochemical Ferric Iron SetIAE · Traditional | 08/22/1977SE |
| K771390 | Histochemical Afb DemonstrationICL · Traditional | 08/22/1977SE |
| K771131 | Clinicard UV Amylase ChemistryJFJ · Traditional | 07/21/1977SE |
| K771094 | Unipak AlbuminCIX · Traditional | 07/21/1977SE |
| K771093 | Unipak CholesterolCGO · Traditional | 07/21/1977SE |
| K771092 | Unipak Total & Direct BilirubinCIG · Traditional | 07/21/1977SE |
| K771091 | Unipak GlucoseCGE · Traditional | 07/21/1977SE |
| K771089 | Unipak Total BilirubinCIG · Traditional | 07/21/1977SE |
| K771088 | Unipak Uric AcidKNK · Traditional | 07/21/1977SE |
| K771087 | Unipak BunCDW · Traditional | 07/21/1977SE |
| K770887 | Auto Total Protein for AnalyzerCEK · Traditional | 07/14/1977SE |
| K770886 | Auto-Enzymatic Glucose for AnalyzerCFR · Traditional | 07/14/1977SE |
| K770883 | Ultrazyme Plus Got · Traditional | 07/14/1977SE |
| K770882 | Ultrazyme Plus GPTCKA · Traditional | 07/14/1977SE |
| K770871 | Ultrazyme Plus HBDJMK · Traditional | 07/14/1977SE |
| K770870 | Ultrazyme Plus AlpCJE · Traditional | 07/14/1977SE |
| K771090 | Unipak HemoglobinGKK · Traditional | 07/11/1977SE |
| K770820 | Ultrachem Inorganic PhosphorusCEO · Traditional | 07/11/1977SE |
| K770819 | Ultrachem CreatinineCGX · Traditional | 07/11/1977SE |
| K770818 | Ultrazyme Plus, LDHCFJ · Traditional | 07/11/1977SE |
| K770817 | Ultrachem CalciumCJY · Traditional | 07/11/1977SE |
| K770816 | Ultrachem AlbuminCIX · Traditional | 07/11/1977SE |
| K770815 | Ultrazyme Plus GT · Traditional | 07/11/1977SE |
| K770229 | Auto-Enzymatic GlucoseCFR · Traditional | 03/01/1977SE |
| K761280 | Auto Creatinine Reagent (Gilford 3400-E)CGX · Traditional | 02/14/1977SE |
| K761279 | Auto Creatinine Reagent (Abbott System)CGX · Traditional | 02/11/1977SE |
| K770121 | Manuel Bilirubin Reagent SetCIG · Traditional | 01/31/1977SE |
| K761240 | Auto-Enzymatic GlucoseCFR · Traditional | 12/29/1976SE |
| K761239 | Auto-Inorganic Phosphorus ReagentCEO · Traditional | 12/29/1976SE |
| K761238 | Auto-Inorganic Phosphorus ReagentCEO · Traditional | 12/29/1976SE |
| K761257 | Auto Total ProteinCEK · Traditional | 12/21/1976SE |
| K761218 | Auto Total Bilirubin ReagentCIG · Traditional | 12/21/1976SE |
| K761217 | Auto Total ProteinCEK · Traditional | 12/21/1976SE |
| K761029 | Auto-Calcium Reag for Gilford 3400E AnalCJY · Traditional | 11/30/1976SE |
| K761028 | Auto-Albumin Reag for Abbott ABA-100CIX · Traditional | 11/30/1976SE |
| K761027 | Auto-Total Bilirubin Reag for Gilford anCIG · Traditional | 11/30/1976SE |
| K760026 | Ultrazyme AmylaseCIJ · Traditional | 09/21/1976SE |
| K760029 | Enzymatic TriglycerideCDT · Traditional | 09/15/1976SE |
| K760028 | CPK - IsoenzymesJHT · Traditional | 09/15/1976SE |
| K760030 | Clinicard PhosphorusCEO · Traditional | 09/13/1976SE |
| K760484 | Stain Set, Histochemical Afb · Traditional | 09/03/1976SE |
| K760025 | Ultrazyme GTJPZ · Traditional | 08/26/1976SE |
| K760024 | Ultrazyme Alkaline PhosphataseCJE · Traditional | 08/26/1976SE |
| K760023 | Ultrazyme HBDJMK · Traditional | 08/26/1976SE |
| K760129 | Saline, Isotonic Buffered, Azide-FreeGIF · Traditional | 07/20/1976SE |
| K760031 | Histochemical Pas Reaction SetHZT · Traditional | 07/20/1976SE |
| K760027 | DSP - Stain PackIAF · Traditional | 07/20/1976SE |