Company ยท US
Biotrol, USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1995. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CIJ | Saccharogenic, Amylase | 2 |
| JGJ | Photometric Method, Magnesium | 2 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 2 |
| JIS | Calibrator, Primary | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 6, 1995 | K934014 | VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT Biotrol, USA, Inc. | LRJ |
| May 26, 1993 | K931141 | BIOTROL AMYLASE CNPG3 Biotrol, USA, Inc. | CIJ |
| Aug 3, 1992 | K921855 | BIOTROL BICARBONATE STANDARDS Biotrol, USA, Inc. | JIS |
| May 26, 1992 | K921677 | BIOTROL MAGNESIUM (MAGON) Biotrol, USA, Inc. | JGJ |
| Aug 12, 1991 | K912795 | BIOTROL UIBC REAGENT Biotrol, USA, Inc. | JMO |
| May 6, 1991 | K910721 | BIOTROL PROTEIN MULTILEVEL STANDARDS Biotrol, USA, Inc. | JIS |
| Mar 11, 1991 | K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) Biotrol, USA, Inc. | CFJ |
| Feb 4, 1991 | K905280 | BIOTROL BILIRUBIN C & T CONTROL Biotrol, USA, Inc. | JJX |
| Aug 30, 1989 | K894544 | BIOTROL RUB-E.I.A. TEST G Biotrol, USA, Inc. | LFX |
| Aug 10, 1989 | K891061 | BIOTROL CALCIUM MONOREACTIF Biotrol, USA, Inc. | CJY |
| Apr 10, 1989 | K891286 | BIOTROL CHEMISTRY URINE CONTROL Biotrol, USA, Inc. | JJW |
| Mar 21, 1989 | K890846 | BIOTROL URINE PROTEINS REAGENT Biotrol, USA, Inc. | JIR |
| Mar 8, 1989 | K890395 | BIOTROL IRON REAGENT Biotrol, USA, Inc. | JIY |
| Feb 17, 1989 | K890015 | BIOTROL CHLORIDE Biotrol, USA, Inc. | CHJ |
| Feb 10, 1989 | K885094 | BIOTROL ALBUMIN Biotrol, USA, Inc. | CIX |
| Jan 30, 1989 | K885053 | BIOTROL URINE PROTEINS REAGENT Biotrol, USA, Inc. | JIR |
| Jan 30, 1989 | K885041 | BIOTROL INORGANIC PHOSPHORUS Biotrol, USA, Inc. | CEO |
| Nov 29, 1988 | K884480 | BIOTROL BILIRUBIN MONOREACTIF Biotrol, USA, Inc. | CIC |
| Sep 13, 1988 | K883428 | BIOTROL URIC ACID ENZYMATIQUE TRINDER Biotrol, USA, Inc. | KNK |
| Jul 8, 1988 | K881742 | BIOTROL ALKALINE PHOSPHATASE Biotrol, USA, Inc. | CJE |
| Jul 1, 1988 | K882189 | BIOTROL TOTAL PROTEIN H.P. Biotrol, USA, Inc. | CEK |
| Jun 16, 1988 | K881856 | BIOTROL CREATININE H.P. REAGENT Biotrol, USA, Inc. | CGX |
| May 27, 1988 | K881702 | BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. Biotrol, USA, Inc. | CDT |
| May 16, 1988 | K881366 | BIOTROL BUN ENZYMATIQUE UV H.P. Biotrol, USA, Inc. | CDQ |
| May 16, 1988 | K881267 | BIOTROL CK MONOEACTIF Biotrol, USA, Inc. | JHX |
| Apr 28, 1988 | K881311 | BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST Biotrol, USA, Inc. | JQB |
| Apr 12, 1988 | K873294 | BIOTROL TOXO ELISA TEST G Biotrol, USA, Inc. | LGD |
| Apr 12, 1988 | K873293 | BIOTROL TOXO ELISA TEST M Biotrol, USA, Inc. | LGD |
| Feb 3, 1988 | K875304 | BIOTROL CALIBRANT LEVEL 2 Biotrol, USA, Inc. | JIX |
| Feb 2, 1988 | K875318 | BIOTROL CALIBRANT LEVEL 3 Biotrol, USA, Inc. | JIX |
| Feb 2, 1988 | K875288 | BIOTROL CALIBRANT LEVEL 1 Biotrol, USA, Inc. | JIX |
| Feb 1, 1988 | K875320 | BIOTROL URIC ACID ENZYMATIQUE UV H.P. Biotrol, USA, Inc. | CDO |
| Jan 7, 1988 | K874809 | REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM Biotrol, USA, Inc. | JJY |
| Jan 5, 1988 | K874941 | BIOTROL BICARBONATE (CO2) UV HP) Biotrol, USA, Inc. | KHS |
| Jan 5, 1988 | K874810 | REFERENCE ASSAYED CHEMISTRY CONTROL SERUM Biotrol, USA, Inc. | JJY |
| Sep 8, 1987 | K873160 | BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR Biotrol, USA, Inc. | CDT |
| Sep 4, 1987 | K872831 | BIOTROL ALPHA AMYLASE Biotrol, USA, Inc. | CIJ |
| Sep 2, 1987 | K873180 | BIOTROL MAGNESIUM CALMAGITE Biotrol, USA, Inc. | JGJ |
| Sep 2, 1987 | K873118 | BIOTROL REFERENCE Biotrol, USA, Inc. | JIX |
| Sep 2, 1987 | K873116 | MULTI ANALYTE MIXTURES, CALIBRATORS Biotrol, USA, Inc. | JIX |
| Aug 31, 1987 | K873117 | BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT Biotrol, USA, Inc. | CGA |
| Aug 26, 1987 | K872785 | BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM Biotrol, USA, Inc. | JJY |
| Aug 26, 1987 | K872777 | BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL Biotrol, USA, Inc. | JJY |
| Aug 21, 1987 | K872930 | BIOTROL CHOLESTEROL ENZYMATIQUE COLOR Biotrol, USA, Inc. | CHH |
| Aug 13, 1987 | K872830 | BIOTROL ALT/TGP MONOREACTIF Biotrol, USA, Inc. | CKA |
| Aug 13, 1987 | K872829 | BIOTROL AST/TGO MONOREACTIF Biotrol, USA, Inc. | CIT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||