Medical Device Manufacturer · US , Walker , MI

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

20 submissions · 20 cleared · Since 1984

Total

Cleared

Denied

Boots-Celltech Diagnostics, Inc. has 20 FDA 510(k) cleared medical devices. Based in Walker, US.

Historical record: 20 cleared submissions from 1984 to 1989. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Boots-Celltech Diagnostics, Inc. Filter by specialty or product code using the sidebar.

Boots-Celltech Diagnostics, 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 - Boots-Celltech Diagnostics, Inc.

20 devices

1-20 of 20

Cleared Nov 17, 1989

IDEIA HERPES SIMPLEX VIRUS TEST

K871877 · LGC

Microbiology · 918d

Cleared Dec 08, 1988

MODIFIED IDEIA CHLAMYDIA TEST

K880799 · LJC

Microbiology · 283d

Cleared Apr 18, 1988

SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY

K880758 · CEP

Chemistry · 53d

Cleared Mar 24, 1988

CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)

K874875 · CEC

Chemistry · 118d

Cleared Feb 24, 1988

IMAGEN INFLUENZA VIRUS A AND B TESTMI

K872958 · GNX

Microbiology · 210d

Cleared Feb 02, 1988

OVEIA (TM) DUAL ANALYTE

K872843 · JLP

Chemistry · 197d

Cleared Oct 20, 1987

CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)

K873625 · JLM

Chemistry · 42d

Cleared Jun 15, 1987

MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST

K872056 · LJC

Microbiology · 18d

Cleared May 08, 1987

IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST

K870602 · GQN

Microbiology · 86d

Cleared Apr 20, 1987

IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

K864998 · JSM

Microbiology · 119d

Cleared Mar 12, 1987

MODIFIED IMAGEN(TM) CHLAMYDIA TEST

K864539 · LJP

Microbiology · 113d

Cleared Aug 19, 1986

MODIFIED IDEIA CHLAMYDIA TEST

K861966 · LJC

Microbiology · 91d

Cleared Aug 19, 1986

SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA

K862439 · CGJ

Chemistry · 54d

Cleared Aug 04, 1986

IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

K862607 · LIO

Microbiology · 27d

Cleared Jun 27, 1986

SUCROSEP HUMAN PROLACTIN (HPR) IRMA

K861271 · CFT

Chemistry · 84d

Cleared Mar 17, 1986

SUCROSEP LUTEINIZING HORMONE (LH) IRMA

K860308 · CEP

Chemistry · 48d

Cleared Feb 28, 1986

SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA

K860228 · CFL

Chemistry · 37d

Cleared Jan 03, 1986

IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST

K854081 · GQG

Microbiology · 88d

Cleared Feb 06, 1985

IMAGEN CHLAMYDIA TEST

K844683 · IWP

Microbiology · 68d

Cleared Sep 12, 1984

SUCROSEP THYROID STIMULATING HORMONE

K842593 · JLW

Chemistry · 71d

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

FDA 510(k) Regulatory Record - Boots-Celltech Diagnostics, Inc.

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