Hoffmann-La Roche, Inc.
Mchenry, IL, US
Hoffmann-La Roche, Inc. appears in FDA device records in Mchenry, IL. FDA records list 49 510(k) clearances between and , 4 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
- 49
- PMA records
- 4
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 49 510(k) clearances for Hoffmann-La Roche, Inc. between 1976 and 1985. The busiest year on record is 1983, with 17. The most recent is 1985, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 2 |
| 1979 | 6 |
| 1980 | 4 |
| 1981 | 9 |
| 1982 | 7 |
| 1983 | 17 |
| 1985 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K850727 | BHCG-ROCHE EIA | JHI | Substantially Equivalent | |
| K831694 | RENAK | CIB | Substantially Equivalent | |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | DJP | Substantially Equivalent | |
| K830481 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE | LCL | Substantially Equivalent | |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | KLN | Substantially Equivalent | |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | DOE | Substantially Equivalent | |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | KXS | Substantially Equivalent | |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | DOE | Substantially Equivalent | |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | DKN | Substantially Equivalent | |
| K823580 | COBAS REAGENT FOR INORGANIC PHOSPHORUS | CEO | Substantially Equivalent | |
| K823579 | COBAS REAGENT FOR TOTAL PROTEIN | CEK | Substantially Equivalent | |
| K823578 | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC | CIO | Substantially Equivalent | |
| K823577 | COBAS REAGENT FOR CALCIUM | CIC | Substantially Equivalent | |
| K823576 | COBAS STANDARD FOR TOTAL PROTEIN | LER | Substantially Equivalent | |
| K823575 | COBAS STANDARDS FOR ALBUMIN | CIX | Substantially Equivalent | |
| K823574 | COBAS REAGENT FOR ALBUMIN | CIX | Substantially Equivalent | |
| K823573 | COBAS REAGENT FOR CREATININE | CGX | Substantially Equivalent | |
| K823572 | COBAS STANDARDS FOR CREATININE | CGX | Substantially Equivalent | |
| K822219 | HUMAN PLASMA CONTROL FOR CEA-ROCHE | JJX | Substantially Equivalent | |
| K823212 | ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE | DJP | Substantially Equivalent | |
| K820942 | ROCHE(R) B-HCG RIA URINE STANDARD | JHI | Substantially Equivalent | |
| K820614 | ROCHE B-HCG STANDARDS | JHI | Substantially Equivalent | |
| K820613 | ROCHE B-HCG RIA | JHI | Substantially Equivalent | |
| K820391 | ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI | LAT | Substantially Equivalent | |
| K812986 | AGGLUTEX AMPHETAMINE TEST KIT | DJP | Substantially Equivalent | |
| K812988 | AGGLUTEX BARBITURATES TEST KIT | DKN | Substantially Equivalent | |
| K812985 | AGGLUTEX MORPHINE TEST KIT | DDF | Substantially Equivalent | |
| K812987 | AGGLUTEX METHAQUALONE TEST KIT | KXS | Substantially Equivalent | |
| K812730 | SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE | JSG | Substantially Equivalent | |
| K812732 | SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE | JSG | Substantially Equivalent | |
| K812731 | SEPTI-CHECK BLOOD CULTURE SLIDE | JSI | Substantially Equivalent | |
| K812729 | SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE | JSG | Substantially Equivalent | |
| K811116 | HCG RADIOIMMUNOASSAY | JHI | Substantially Equivalent | |
| K810905 | ISOMUNE-CK | JHW | Substantially Equivalent | |
| K801244 | ROCHE HCG STANDARDS | JHI | Substantially Equivalent | |
| K792671 | COBAS-BIO CENTRIFUGAL ANALYZER | JJG | Substantially Equivalent | |
| K792658 | COBAS-BLO REAGENTS (LACTATE DEHYDRO | CFJ | Substantially Equivalent | |
| K792657 | SENSI-SLIDE | JHJ | Substantially Equivalent | |
| K791373 | ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS | CFE | Substantially Equivalent | |
| K791206 | HCG RIA PREGNANCY TEST | JHI | Substantially Equivalent | |
| K790655 | ABUSCREEN RIA FOR PHENCYCLIDINE | LCL | Substantially Equivalent | |
| K790485 | AMYLOCHROME STAT SEPARATOR, TEST | JKA | Substantially Equivalent | |
| K790357 | CPK-CS | JHT | Substantially Equivalent | |
| K790267 | SENSI-TEX | JHJ | Substantially Equivalent | |
| K781236 | ENTEROTUBE II | JSS | Substantially Equivalent | |
| K780428 | ROCHE TSH RIA | JLW | Substantially Equivalent | |
| K771623 | T3 RIA | CDP | Substantially Equivalent | |
| K770467 | IN VITRO DIAGNOSTIC TEST | Substantially Equivalent | ||
| K760089 | TEST, IN-VITRO DIAGNOSTIC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJGAnalyzer, Chemistry, Centrifugal, For Clinical Use
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JHTChromatographic Separation, Cpk Isoenzymes
- CICCresolphthalein Complexone, Calcium
- JSGCulture Media, Non-Selective And Non-Differential
- JSICulture Media, Selective And Differential
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes
- LERFluorescent Immunoassay, Theophylline
- JSSKit, Identification, Enterobacteriaceae
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- DDFProthrombin, Antigen, Antiserum, Control
- DJPRadioimmunoassay, Amphetamine
- CIBRadioimmunoassay, Angiotensin I And Renin
- DKNRadioimmunoassay, Barbiturate
- LATRadioimmunoassay, Cannabinoid(S)
- KLNRadioimmunoassay, Cocaine Metabolite
- KXSRadioimmunoassay, Methaqualone
- DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
- LCLRadioimmunoassay, Phencyclidine
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHXSystem, Test, Carcinoembryonic Antigen
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- JHWU.V. Method, Cpk Isoenzymes
- JHIVisual, Pregnancy Hcg, Prescription Use
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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Hoffmann-La Roche, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Hoffmann-La Roche, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain