Medical Device Manufacturer · US , Mchenry , IL

Behring Diagnostics, Inc. - FDA 510(k) Cleared Devices

145 submissions · 145 cleared · Since 1976

145

Total

145

Cleared

0

Denied

FDA 510(k) Regulatory Record - Behring Diagnostics, Inc. Immunology ✕

53 devices

1-12 of 53

Cleared Oct 20, 1997

N ANTISERUM TO HUMAN ALBUMIN

Immunology · 73d

Cleared Oct 17, 1997

N ANTISERUM TO HUMAN TRANSFERRIN

Immunology · 77d

Cleared Sep 12, 1997

MODIFICATION OF OPUS FERRITIN TEST SYSTEM

Immunology · 66d

Cleared Jun 24, 1997

OPUS PSA TEST SYSTEM

Immunology · 218d

Cleared Jan 15, 1997

N RHEUMATOLOGY STANDARD SL

Immunology · 64d

Cleared Dec 16, 1996

N LATEX CRP MONO REAGENT

Immunology · 90d

Cleared Oct 03, 1996

N LATEX B2-MICROGLOBULIN REAGENT

Immunology · 300d

Cleared Aug 15, 1996

OPUS MYOGLOBIN CONTROLS

Immunology · 24d

Cleared Aug 01, 1996

N ANTISERUM TO C1 INHIBITOR

Immunology · 196d

Cleared Jul 11, 1996

N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2

Immunology · 21d

Cleared Jul 10, 1996

N LATEX CRP MONO REAGENT

Immunology · 41d

Cleared Feb 21, 1996

N PROTEIN STANDARS SY

Immunology · 56d

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