Medical Device Manufacturer · US , Mchenry , IL

Hoffmann-La Roche, Inc. - FDA 510(k) Cleared Devices

49 submissions · 49 cleared · Since 1976

Recent clearances: BHCG-ROCHE EIA, RENAK, ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE

View 49 510(k) Devices ↓ Official Website

49

Total

49

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hoffmann-La Roche, Inc. Immunology ✕

3 devices

1-3 of 3

Cleared Dec 28, 1982

HUMAN PLASMA CONTROL FOR CEA-ROCHE

Immunology · 155d

Cleared Apr 27, 1977

IN VITRO DIAGNOSTIC TEST

Immunology · 48d

Cleared Jul 20, 1976

TEST, IN-VITRO DIAGNOSTIC

Immunology · 29d