Harleco Diagnostics
Medical device manufacturer in Mchenry, IL.
23510(k) clearances
0PMA approvals
0recalls
Device types
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 2
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 2
- CIX Bromcresol Green Dye-Binding, Albumin 2
- JIS Calibrator, Primary 1
- JIT Calibrator, Secondary 1
- CDW Diacetyl-Monoxime, Urea Nitrogen 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- CEX Chromatographic Separation, Lactate… 1
- JMK Acid, Alpha-Ketobutyric And Nadh (U.V.)… 1
- CIG Diazo Colorimetry, Bilirubin 1
- CDO Acid, Uric, Uricase (U.V.) 1
- JPZ Colorimetric Method, Gamma-Glutamyl… 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- JFJ Catalytic Methods, Amylase 1
- CFR Hexokinase, Glucose 1
- LFR Glucose Dehydrogenase, Glucose 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K823147 | Uric Acid Standard, 8MG/DL #65078JIS · Traditional | 11/22/1982SE |
| K822852 | Triglyceride CalibratorJIT · Traditional | 10/27/1982SE |
| K822323 | Ultrachem Bun-Uv, 65080 & 65081CDW · Traditional | 09/02/1982SE |
| K821883 | Ultrazyme Plus Ck-ICGS · Traditional | 07/14/1982SE |
| K821882 | Ultrazyme Plus GPTCKA · Traditional | 07/14/1982SE |
| K821881 | Ultrachem CreaCGX · Traditional | 07/14/1982SE |
| K821880 | Ultra Chem AlbCIX · Traditional | 07/14/1982SE |
| K821879 | Ultrachem T.P.CEX · Traditional | 07/14/1982SE |
| K821878 | Ultrazyme Plus LDHCFJ · Traditional | 07/14/1982SE |
| K821877 | Ultrazyme Plus HBDJMK · Traditional | 07/14/1982SE |
| K821873 | Ultrachem T-BiliCIG · Traditional | 07/14/1982SE |
| K821872 | Ultrachem Uric Acid AidhCDO · Traditional | 07/14/1982SE |
| K821871 | Ultrazyme Plus 2GTJPZ · Traditional | 07/14/1982SE |
| K821876 | Ultrazyme Plus GotCIT · Traditional | 07/13/1982SE |
| K821875 | Ultrachem Tri-EsCDT · Traditional | 07/13/1982SE |
| K821874 | Ultrachem PhosCEO · Traditional | 07/13/1982SE |
| K821870 | Ultrazyme Plus AlpCJE · Traditional | 07/13/1982SE |
| K821869 | Ultrazyme Plus AmylJFJ · Traditional | 07/13/1982SE |
| K821868 | Ultrachem E-GluCFR · Traditional | 07/08/1982SE |
| K821867 | Ultrachem Gluc-DhLFR · Traditional | 07/06/1982SE |
| K770694 | CPK Ultrazyme PlusCGS · Traditional | 07/01/1977SE |
| K770613 | LDH Ultrazyme PlusCFJ · Traditional | 06/17/1977SE |
| K761026 | Auto-Albumin Reag for Gilford 3400E AnalCIX · Traditional | 11/30/1976SE |