Hoffmann-La Roche, Inc.
Medical device manufacturer in Nutley, NJ.
49510(k) clearances
0PMA approvals
0recalls
Device types
- JHI Visual, Pregnancy Hcg, Prescription Use 7
- DJP Radioimmunoassay, Amphetamine 3
- JSG Culture Media, Non-Selective And… 3
- CGX Alkaline Picrate, Colorimetry, Creatinine 2
- CIX Bromcresol Green Dye-Binding, Albumin 2
- JHJ Agglutination Method, Human Chorionic… 2
- DOE Radioimmunoassay, Morphine (125-I), Goat… 2
- LCL Radioimmunoassay, Phencyclidine 2
- DKN Radioimmunoassay, Barbiturate 2
- KXS Radioimmunoassay, Methaqualone 2
- JJG Analyzer, Chemistry, Centrifugal, For… 1
- DDF Prothrombin, Antigen, Antiserum, Control 1
- CIB Radioimmunoassay, Angiotensin I And Renin 1
- JHW U.V. Method, Cpk Isoenzymes 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 1
- CFE Electrophoretic, Lactate Dehydrogenase… 1
- JKA Tubes, Vials, Systems, Serum Separators… 1
- JHT Chromatographic Separation, Cpk Isoenzymes 1
- JSS Kit, Identification, Enterobacteriaceae 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K850727 | Bhcg-Roche EiaJHI · Traditional | 06/25/1985SE |
| K831694 | RenakCIB · Traditional | 07/19/1983SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | 03/24/1983SE |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | 03/24/1983SE |
| K830480 | Abuscreen Radioimmunoassay-Cocaine MetaKLN · Traditional | 03/24/1983SE |
| K830462 | Abuscreen Radioummunoassay--UrineDOE · Traditional | 03/24/1983SE |
| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | 03/24/1983SE |
| K830460 | Abuscreen Radioimmunoassay for MorphineDOE · Traditional | 03/24/1983SE |
| K830479 | Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional | 03/10/1983SE |
| K823580 | Cobas Reagent for Inorganic PhosphorusCEO · Traditional | 01/07/1983SE |
| K823579 | Cobas Reagent for Total ProteinCEK · Traditional | 01/07/1983SE |
| K823578 | Cobas Standards for Calcium-In-OrganicCIO · Traditional | 01/07/1983SE |
| K823577 | Cobas Reagent for CalciumCIC · Traditional | 01/07/1983SE |
| K823576 | Cobas Standard for Total ProteinLER · Traditional | 01/07/1983SE |
| K823575 | Cobas Standards for AlbuminCIX · Traditional | 01/07/1983SE |
| K823574 | Cobas Reagent for AlbuminCIX · Traditional | 01/07/1983SE |
| K823573 | Cobas Reagent for CreatinineCGX · Traditional | 01/07/1983SE |
| K823572 | Cobas Standards for CreatinineCGX · Traditional | 01/07/1983SE |
| K822219 | Human Plasma Control for Cea-RocheJJX · Traditional | 12/28/1982SE |
| K823212 | Abuscreen Radioimmunoassay - AmphetamineDJP · Traditional | 11/29/1982SE |
| K820942 | Roche(R) B-Hcg Ria Urine StandardJHI · Traditional | 05/03/1982SE |
| K820614 | Roche B-Hcg StandardsJHI · Traditional | 04/01/1982SE |
| K820613 | Roche B-Hcg RiaJHI · Traditional | 04/01/1982SE |
| K820391 | Abuscreen Radioimmunoassay for CannabiLAT · Traditional | 03/08/1982SE |
| K812986 | Agglutex Amphetamine Test KitDJP · Traditional | 01/22/1982SE |
| K812988 | Agglutex Barbiturates Test KitDKN · Traditional | 12/31/1981SE |
| K812985 | Agglutex Morphine Test KitDDF · Traditional | 12/31/1981SE |
| K812987 | Agglutex Methaqualone Test KitKXS · Traditional | 12/22/1981SE |
| K812730 | Septi-Chek Columbia Broth Blood CultureJSG · Traditional | 10/23/1981SE |
| K812732 | Septi-Chek BH1 Blood Culture BottleJSG · Traditional | 10/19/1981SE |
| K812731 | Septi-Check Blood Culture SlideJSI · Traditional | 10/19/1981SE |
| K812729 | Septi-Chek Blood Culture Bottle RocheJSG · Traditional | 10/19/1981SE |
| K811116 | HCG RadioimmunoassayJHI · Traditional | 05/13/1981SE |
| K810905 | Isomune-CkJHW · Traditional | 04/14/1981SE |
| K801244 | Roche HCG StandardsJHI · Traditional | 06/20/1980SE |
| K792671 | Cobas-Bio Centrifugal AnalyzerJJG · Traditional | 01/17/1980SE |
| K792658 | Cobas-Blo Reagents (Lactate DehydroCFJ · Traditional | 01/17/1980SE |
| K792657 | Sensi-SlideJHJ · Traditional | 01/16/1980SE |
| K791373 | Roche Immunochemical LD Isoenzy ReagentsCFE · Traditional | 10/26/1979SE |
| K791206 | HCG Ria Pregnancy TestJHI · Traditional | 07/30/1979SE |
| K790655 | Abuscreen Ria for PhencyclidineLCL · Traditional | 06/15/1979SE |
| K790485 | Amylochrome Stat Separator, TestJKA · Traditional | 05/03/1979SE |
| K790357 | Cpk-CsJHT · Traditional | 04/04/1979SE |
| K790267 | Sensi-TexJHJ · Traditional | 03/21/1979SE |
| K781236 | Enterotube IIJSS · Traditional | 08/31/1978SE |
| K780428 | Roche TSH RiaJLW · Traditional | 03/30/1978SE |
| K771623 | T3 RiaCDP · Traditional | 09/20/1977SE |
| K770467 | In Vitro Diagnostic Test · Traditional | 04/27/1977SE |
| K760089 | Test, In-Vitro Diagnostic · Traditional | 07/20/1976SE |