Company ยท US
Hoffmann-La Roche, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1985. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 7 |
| DJP | Radioimmunoassay, Amphetamine | 3 |
| JSG | Culture Media, Non-Selective And Non-Differential | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 |
| DKN | Radioimmunoassay, Barbiturate | 2 |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 |
| KXS | Radioimmunoassay, Methaqualone | 2 |
| LCL | Radioimmunoassay, Phencyclidine | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| DDF | Prothrombin, Antigen, Antiserum, Control | 1 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 1985 | K850727 | BHCG-ROCHE EIA Hoffmann-La Roche, Inc. | JHI |
| Jul 19, 1983 | K831694 | RENAK Hoffmann-La Roche, Inc. | CIB |
| Mar 24, 1983 | K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE Hoffmann-La Roche, Inc. | DJP |
| Mar 24, 1983 | K830481 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE Hoffmann-La Roche, Inc. | LCL |
| Mar 24, 1983 | K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META Hoffmann-La Roche, Inc. | KLN |
| Mar 24, 1983 | K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE Hoffmann-La Roche, Inc. | DOE |
| Mar 24, 1983 | K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE Hoffmann-La Roche, Inc. | KXS |
| Mar 24, 1983 | K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE Hoffmann-La Roche, Inc. | DOE |
| Mar 10, 1983 | K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE Hoffmann-La Roche, Inc. | DKN |
| Jan 7, 1983 | K823580 | COBAS REAGENT FOR INORGANIC PHOSPHORUS Hoffmann-La Roche, Inc. | CEO |
| Jan 7, 1983 | K823579 | COBAS REAGENT FOR TOTAL PROTEIN Hoffmann-La Roche, Inc. | CEK |
| Jan 7, 1983 | K823578 | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC Hoffmann-La Roche, Inc. | CIO |
| Jan 7, 1983 | K823577 | COBAS REAGENT FOR CALCIUM Hoffmann-La Roche, Inc. | CIC |
| Jan 7, 1983 | K823576 | COBAS STANDARD FOR TOTAL PROTEIN Hoffmann-La Roche, Inc. | LER |
| Jan 7, 1983 | K823575 | COBAS STANDARDS FOR ALBUMIN Hoffmann-La Roche, Inc. | CIX |
| Jan 7, 1983 | K823574 | COBAS REAGENT FOR ALBUMIN Hoffmann-La Roche, Inc. | CIX |
| Jan 7, 1983 | K823573 | COBAS REAGENT FOR CREATININE Hoffmann-La Roche, Inc. | CGX |
| Jan 7, 1983 | K823572 | COBAS STANDARDS FOR CREATININE Hoffmann-La Roche, Inc. | CGX |
| Dec 28, 1982 | K822219 | HUMAN PLASMA CONTROL FOR CEA-ROCHE Hoffmann-La Roche, Inc. | JJX |
| Nov 29, 1982 | K823212 | ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE Hoffmann-La Roche, Inc. | DJP |
| May 3, 1982 | K820942 | ROCHE(R) B-HCG RIA URINE STANDARD Hoffmann-La Roche, Inc. | JHI |
| Apr 1, 1982 | K820614 | ROCHE B-HCG STANDARDS Hoffmann-La Roche, Inc. | JHI |
| Apr 1, 1982 | K820613 | ROCHE B-HCG RIA Hoffmann-La Roche, Inc. | JHI |
| Mar 8, 1982 | K820391 | ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI Hoffmann-La Roche, Inc. | LAT |
| Jan 22, 1982 | K812986 | AGGLUTEX AMPHETAMINE TEST KIT Hoffmann-La Roche, Inc. | DJP |
| Dec 31, 1981 | K812988 | AGGLUTEX BARBITURATES TEST KIT Hoffmann-La Roche, Inc. | DKN |
| Dec 31, 1981 | K812985 | AGGLUTEX MORPHINE TEST KIT Hoffmann-La Roche, Inc. | DDF |
| Dec 22, 1981 | K812987 | AGGLUTEX METHAQUALONE TEST KIT Hoffmann-La Roche, Inc. | KXS |
| Oct 23, 1981 | K812730 | SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE Hoffmann-La Roche, Inc. | JSG |
| Oct 19, 1981 | K812732 | SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE Hoffmann-La Roche, Inc. | JSG |
| Oct 19, 1981 | K812731 | SEPTI-CHECK BLOOD CULTURE SLIDE Hoffmann-La Roche, Inc. | JSI |
| Oct 19, 1981 | K812729 | SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE Hoffmann-La Roche, Inc. | JSG |
| May 13, 1981 | K811116 | HCG RADIOIMMUNOASSAY Hoffmann-La Roche, Inc. | JHI |
| Apr 14, 1981 | K810905 | ISOMUNE-CK Hoffmann-La Roche, Inc. | JHW |
| Jun 20, 1980 | K801244 | ROCHE HCG STANDARDS Hoffmann-La Roche, Inc. | JHI |
| Jan 17, 1980 | K792671 | COBAS-BIO CENTRIFUGAL ANALYZER Hoffmann-La Roche, Inc. | JJG |
| Jan 17, 1980 | K792658 | COBAS-BLO REAGENTS (LACTATE DEHYDRO Hoffmann-La Roche, Inc. | CFJ |
| Jan 16, 1980 | K792657 | SENSI-SLIDE Hoffmann-La Roche, Inc. | JHJ |
| Oct 26, 1979 | K791373 | ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS Hoffmann-La Roche, Inc. | CFE |
| Jul 30, 1979 | K791206 | HCG RIA PREGNANCY TEST Hoffmann-La Roche, Inc. | JHI |
| Jun 15, 1979 | K790655 | ABUSCREEN RIA FOR PHENCYCLIDINE Hoffmann-La Roche, Inc. | LCL |
| May 3, 1979 | K790485 | AMYLOCHROME STAT SEPARATOR, TEST Hoffmann-La Roche, Inc. | JKA |
| Apr 4, 1979 | K790357 | CPK-CS Hoffmann-La Roche, Inc. | JHT |
| Mar 21, 1979 | K790267 | SENSI-TEX Hoffmann-La Roche, Inc. | JHJ |
| Aug 31, 1978 | K781236 | ENTEROTUBE II Hoffmann-La Roche, Inc. | JSS |
| Mar 30, 1978 | K780428 | ROCHE TSH RIA Hoffmann-La Roche, Inc. | JLW |
| Sep 20, 1977 | K771623 | T3 RIA Hoffmann-La Roche, Inc. | CDP |
| Apr 27, 1977 | K770467 | IN VITRO DIAGNOSTIC TEST Hoffmann-La Roche, Inc. | |
| Jul 20, 1976 | K760089 | TEST, IN-VITRO DIAGNOSTIC Hoffmann-La Roche, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||