Biochemical Trade, Inc.
Miami, FL, US
Biochemical Trade, Inc. appears in FDA device records in Miami, FL. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Biochemical Trade, Inc. between 1987 and 1994. The busiest year on record is 1987, with 10. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 10 |
| 1991 | 9 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | JHW | Substantially Equivalent | |
| K910635 | TOTAL BILIRUBIN REAGENT SET | CIG | Substantially Equivalent | |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | CEO | Substantially Equivalent | |
| K905776 | ALBUMIN REAGENT SET | CJW | Substantially Equivalent | |
| K905790 | TOTAL PROTEIN REAGENT SET | CEK | Substantially Equivalent | |
| K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION | CJE | Substantially Equivalent | |
| K905619 | CREATININE (RATE) REAGENT SET | CGX | Substantially Equivalent | |
| K905651 | KINETIC AMYLASE DETERMINATION | JFJ | Substantially Equivalent | |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | JQB | Substantially Equivalent | |
| K905588 | CREATINE KINASE UV REAGENT SET | JHW | Substantially Equivalent | |
| K871547 | ULTRA-VIOLET BUN REAGENT KIT (RATE) | CDQ | Substantially Equivalent | |
| K871780 | ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) | CIT | Substantially Equivalent | |
| K871781 | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET | CFJ | Substantially Equivalent | |
| K871782 | ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) | CKA | Substantially Equivalent | |
| K871651 | COLORIMETRIC BUN REAGENT KIT | CDL | Substantially Equivalent | |
| K871650 | GLUCOSE ENZYME - COLOR REAGENT SET | CGA | Substantially Equivalent | |
| K871456 | ULTRA-VIOLET GLUCOSE REAGENT KIT | CFR | Substantially Equivalent | |
| K871417 | COLORIMETRIC URIC ACID REAGENT SET | KNK | Substantially Equivalent | |
| K871260 | CHOLESTEROL DETERMINATION | CHH | Substantially Equivalent | |
| K871122 | TRIGLYCERIDES DETERMINATION | CDT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CDLBerthelot Indophenol, Urea Nitrogen
- CEKBiuret (Colorimetric), Total Protein
- CJWBromcresol Purple Dye-Binding, Albumin
- JFJCatalytic Methods, Amylase
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JHWU.V. Method, Cpk Isoenzymes
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain