Roche Analytical Instruments, Inc.
Mchenry, IL, US
Roche Analytical Instruments, Inc. appears in FDA device records in Mchenry, IL. FDA records list 11 510(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
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Roche Analytical Instruments, Inc. in 1980.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 11 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K801299 | COBAS CK-NAC REAGENT | CGS | Substantially Equivalent | |
| K801298 | COBAS REAGENT FOR TRIGLYCERIDES & COBAS | CDT | Substantially Equivalent | |
| K801295 | COBAS REAGENT FOR A-AMYLASE | JFJ | Substantially Equivalent | |
| K801297 | COBAS REAGENT FOR GLUCOSE RAPID | CFR | Substantially Equivalent | |
| K801296 | COBAS REAGENT FOR CHOLESTEROL | CHH | Substantially Equivalent | |
| K801243 | COBAS REAGENTS FOR URIC ACID | CDO | Substantially Equivalent | |
| K801242 | COBAS REAGENT FOR ALKALINE PHOSPHATASE | CJE | Substantially Equivalent | |
| K801118 | COBAS REAGENT FOR AST (SGOT) | CIT | Substantially Equivalent | |
| K801116 | COBAS REAGENT FOR BUN | CDQ | Substantially Equivalent | |
| K801119 | COBAS REAGENT FOR ALT (GPT) | CKA | Substantially Equivalent | |
| K801117 | COBAS TOTAL BILIRUBIN REAGENT & DILUENT | CIG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDOAcid, Uric, Uricase (U.V.)
- JFJCatalytic Methods, Amylase
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CFRHexokinase, Glucose
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain