Medical Device Manufacturer · US , Walker , MI

Wellcome Diagnostics - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1983

Recent clearances: D-DIMER WELLCOTEST (HA10), STREPTEX ACID EXTRACTION KIT, WELLCOLEX COLOUR SHIGELLA TEST ZC51

28

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Wellcome Diagnostics Chemistry ✕

6 devices

1-6 of 6

Cleared Sep 29, 1983

DIACROM * FACTOR X KIT HA31

Chemistry · 73d

Cleared Sep 29, 1983

DIACROM * HEPARIN

Chemistry · 73d

Cleared Sep 01, 1983

DAC-CEL HCG-MCA KIT RD52

Chemistry · 150d

Cleared Jun 16, 1983

DAC-CEL PTH KIT RD51

Chemistry · 73d

Cleared Feb 18, 1983

DAC-CEL DIAGNATAL RD 50

Chemistry · 29d

Cleared Feb 18, 1983

DAC-CEL DIAGNATAL HCG STANDARDS RD49

Chemistry · 29d