Medical Device Manufacturer · US , Walker , MI

Wellcome Diagnostics - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1983

Total

Cleared

Denied

Wellcome Diagnostics has 28 FDA 510(k) cleared medical devices. Based in Walker, US.

Historical record: 28 cleared submissions from 1983 to 1992. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Wellcome Diagnostics Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Wellcome Diagnostics

28 devices

1-12 of 28

Cleared Jan 31, 1992

D-DIMER WELLCOTEST (HA10)

K915203 · DAP

Hematology · 74d

Cleared Mar 29, 1991

STREPTEX ACID EXTRACTION KIT

K910797 · GTZ

Microbiology · 31d

Cleared Jan 11, 1990

WELLCOLEX COLOUR SHIGELLA TEST ZC51

K895461 · GNB

Microbiology · 127d

Cleared Feb 16, 1989

WELLCOLEX COLOUR SALMONELLA TEST ZL 50

WELLCOZYME ROTAVIRUS WZ01

K861628 · LIQ

Microbiology · 267d

Cleared Jan 13, 1987

REVEAL COLOUR STREP A ZL16

K864206 · GTZ

Microbiology · 78d

Cleared Oct 29, 1986

THE WELLCOME ROTAVIRUS LATEX TEST ZL40

K861634 · LIQ

Microbiology · 183d

Cleared Feb 04, 1986

WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24

K854851 · GTJ

Microbiology · 61d

Cleared Feb 04, 1986

WELLCOGEN BACTERIAL ANTIGEN KIT

K854852 · GTJ

Microbiology · 61d

Cleared Jun 10, 1985

WILLCOGEN MENINGITIDIS KIT ZL25

K851691 · GTJ

Microbiology · 48d

Cleared Jun 04, 1985

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51

K844762 · GTJ

Immunology · 179d

Wellcome Diagnostics - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by Wellcome Diagnostics

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