Medical Device Manufacturer · US , Walker , MI

Diagnostic Reagents, Inc. - FDA 510(k) Cleared Devices

66 submissions · 66 cleared · Since 1982

66

Total

66

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diagnostic Reagents, Inc. Chemistry ✕

11 devices

1-11 of 11

Cleared Oct 20, 1995

Chemistry · 164d

Cleared Jun 15, 1995

T-UPTAKE CALIBRATORS

Chemistry · 70d

Cleared May 15, 1995

T-UPTAKE EIA TEST

Chemistry · 39d

Cleared Dec 09, 1994

THYROXINE ENZYME IMMUNOASSAY

Chemistry · 77d

Cleared Nov 21, 1994

Chemistry · 59d

Cleared Dec 03, 1993

COCAINE METABOLITE EIA ASSAY MODIFICATION

Chemistry · 46d

Cleared Jun 24, 1982

T3 UPTAKE DIAGNOSTIC KIT

Chemistry · 14d

Cleared Jun 24, 1982

T3 DIAGNOSTIC KIT RIA

Chemistry · 16d

Cleared May 12, 1982

SIMUL-FER SERUM IRON TEST KIT

Chemistry · 103d

Cleared May 05, 1982

T4 DIAGNOSTIC KIT

Chemistry · 96d

Cleared May 05, 1982

TBG DIAGNOSTIC KIT

Chemistry · 96d