Medical Device Manufacturer · US , Walker , MI

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

20 submissions · 20 cleared · Since 1984

Recent clearances: IDEIA HERPES SIMPLEX VIRUS TEST, MODIFIED IDEIA CHLAMYDIA TEST, SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY

20

Total

20

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared Apr 18, 1988

SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY

Chemistry · 53d

Cleared Mar 24, 1988

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

Chemistry · 118d

Cleared Feb 02, 1988

OVEIA (TM) DUAL ANALYTE

Chemistry · 197d

Cleared Oct 20, 1987

CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)

Chemistry · 42d

Cleared Aug 19, 1986

SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA

Chemistry · 54d

Cleared Jun 27, 1986

SUCROSEP HUMAN PROLACTIN (HPR) IRMA

Chemistry · 84d

Cleared Mar 17, 1986

SUCROSEP LUTEINIZING HORMONE (LH) IRMA

Chemistry · 48d

Cleared Feb 28, 1986

SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA

Chemistry · 37d

Cleared Sep 12, 1984

SUCROSEP THYROID STIMULATING HORMONE

Chemistry · 71d