Medical Device Manufacturer · US , Mchenry , IL

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

49 submissions · 49 cleared · Since 1976

Total

Cleared

Denied

Hoffmann-La Roche, Inc. has 49 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 49 cleared submissions from 1976 to 1985. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Hoffmann-La Roche, Inc. Filter by specialty or product code using the sidebar.

Hoffmann-La Roche, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

49 devices

1-12 of 49

ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE

K830460 · DOE

Toxicology · 37d

Cleared Mar 24, 1983

ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE

K830461 · KXS

Toxicology · 37d

Cleared Mar 24, 1983

ABUSCREEN RADIOUMMUNOASSAY--URINE

K830462 · DOE

Toxicology · 37d

Cleared Mar 24, 1983

ABUSCREEN RADIOIMMUNOASSAY-COCAINE META

K830480 · KLN

Toxicology · 37d

Cleared Mar 24, 1983

ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE

K830481 · LCL

Toxicology · 37d

Cleared Mar 24, 1983

ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE

K830482 · DJP

Toxicology · 37d

Cleared Mar 10, 1983

ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE

K830479 · DKN

Toxicology · 23d

Cleared Jan 07, 1983

COBAS STANDARDS FOR CREATININE

K823572 · CGX

Chemistry · 32d

Cleared Jan 07, 1983

COBAS REAGENT FOR CREATININE

K823573 · CGX

Chemistry · 32d

Cleared Jan 07, 1983

COBAS REAGENT FOR ALBUMIN

K823574 · CIX

Chemistry · 32d

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

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

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