Biotrol, USA, Inc.
Medical device manufacturer in Louisville, CO.
46510(k) clearances
0PMA approvals
0recalls
Device types
- JIX Calibrator, Multi-Analyte Mixture 5
- JJY Multi-Analyte Controls, All Kinds (Assayed) 4
- JIR Indicator Method, Protein Or Albumin… 2
- JIS Calibrator, Primary 2
- JGJ Photometric Method, Magnesium 2
- CIJ Saccharogenic, Amylase 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 2
- LGD Enzyme Linked Immunoabsorbent Assay… 2
- CDO Acid, Uric, Uricase (U.V.) 1
- KNK Acid, Uric, Uricase (Colorimetric) 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- LRJ Disinfectant, Medical Devices 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- CDQ Urease And Glutamic Dehydrogenase, Urea… 1
- JHX Fluorometric Method, Cpk Or Isoenzymes 1
- JQB Kinetic Method, Gamma-Glutamyl Transpeptidase 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- KHS Enzymatic, Carbon-Dioxide 1
- CGA Glucose Oxidase, Glucose 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K934014 | Vacusol Plus Dental Vacuum Line Cleaner/DisinfectantLRJ · Traditional | 12/06/1995SE |
| K931141 | Biotrol Amylase CNPG3CIJ · Traditional | 05/26/1993SE |
| K921855 | Biotrol Bicarbonate StandardsJIS · Traditional | 08/03/1992SE |
| K921677 | Biotrol Magnesium (Magon)JGJ · Traditional | 05/26/1992SE |
| K912795 | Biotrol Uibc ReagentJMO · Traditional | 08/12/1991SE |
| K910721 | Biotrol Protein Multilevel StandardsJIS · Traditional | 05/06/1991SE |
| K905683 | Biotrol Lactate Dehydrogenase (L-P)CFJ · Traditional | 03/11/1991SE |
| K905280 | Biotrol Bilirubin C & T ControlJJX · Traditional | 02/04/1991SE |
| K894544 | Biotrol Rub-E.I.A. Test GLFX · Traditional | 08/30/1989SE |
| K891061 | Biotrol Calcium MonoreactifCJY · Traditional | 08/10/1989SE |
| K891286 | Biotrol Chemistry Urine ControlJJW · Traditional | 04/10/1989SE |
| K890846 | Biotrol Urine Proteins ReagentJIR · Traditional | 03/21/1989SE |
| K890395 | Biotrol Iron ReagentJIY · Traditional | 03/08/1989SE |
| K890015 | Biotrol ChlorideCHJ · Traditional | 02/17/1989SE |
| K885094 | Biotrol AlbuminCIX · Traditional | 02/10/1989SE |
| K885053 | Biotrol Urine Proteins ReagentJIR · Traditional | 01/30/1989SE |
| K885041 | Biotrol Inorganic PhosphorusCEO · Traditional | 01/30/1989SE |
| K884480 | Biotrol Bilirubin MonoreactifCIC · Traditional | 11/29/1988SE |
| K883428 | Biotrol Uric Acid Enzymatique TrinderKNK · Traditional | 09/13/1988SE |
| K881742 | Biotrol Alkaline PhosphataseCJE · Traditional | 07/08/1988SE |
| K882189 | Biotrol Total Protein H.P.CEK · Traditional | 07/01/1988SE |
| K881856 | Biotrol Creatinine H.P. ReagentCGX · Traditional | 06/16/1988SE |
| K881702 | Biotrol Triglycerides Enzymatique UV H.P.CDT · Traditional | 05/27/1988SE |
| K881366 | Biotrol Bun Enzymatique UV H.P.CDQ · Traditional | 05/16/1988SE |
| K881267 | Biotrol CK MonoeactifJHX · Traditional | 05/16/1988SE |
| K881311 | Biotrol -Gt Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 04/28/1988SE |
| K873294 | Biotrol Toxo Elisa Test GLGD · Traditional | 04/12/1988SE |
| K873293 | Biotrol Toxo Elisa Test MLGD · Traditional | 04/12/1988SE |
| K875304 | Biotrol Calibrant Level 2JIX · Traditional | 02/03/1988SE |
| K875318 | Biotrol Calibrant Level 3JIX · Traditional | 02/02/1988SE |
| K875288 | Biotrol Calibrant Level 1JIX · Traditional | 02/02/1988SE |
| K875320 | Biotrol Uric Acid Enzymatique UV H.P.CDO · Traditional | 02/01/1988SE |
| K874809 | Reference High Level Assayed Chem. Control SerumJJY · Traditional | 01/07/1988SE |
| K874941 | Biotrol Bicarbonate (CO2) UV HP)KHS · Traditional | 01/05/1988SE |
| K874810 | Reference Assayed Chemistry Control SerumJJY · Traditional | 01/05/1988SE |
| K873160 | Biotrol Triglycerides Enzymatique ColorCDT · Traditional | 09/08/1987SE |
| K872831 | Biotrol Alpha AmylaseCIJ · Traditional | 09/04/1987SE |
| K873180 | Biotrol Magnesium CalmagiteJGJ · Traditional | 09/02/1987SE |
| K873118 | Biotrol ReferenceJIX · Traditional | 09/02/1987SE |
| K873116 | Multi Analyte Mixtures, CalibratorsJIX · Traditional | 09/02/1987SE |
| K873117 | Biotrol Glucose Enzymatique Color ReagentCGA · Traditional | 08/31/1987SE |
| K872785 | BIOTROL-33 Plus Assayed Chemistry Control SerumJJY · Traditional | 08/26/1987SE |
| K872777 | BIOTROL-33 Plus Pathologique Assayed Chem. ControlJJY · Traditional | 08/26/1987SE |
| K872930 | Biotrol Cholesterol Enzymatique ColorCHH · Traditional | 08/21/1987SE |
| K872830 | Biotrol Alt/Tgp MonoreactifCKA · Traditional | 08/13/1987SE |
| K872829 | Biotrol Ast/Tgo MonoreactifCIT · Traditional | 08/13/1987SE |