Hybritech, Inc. - FDA 510(k) Cleared Devices

Cleared Sep 11, 1997

TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY

K972666 · CIN

Chemistry · 57d

Cleared Aug 19, 1996

TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY

K961573 · CIN

Chemistry · 118d

Cleared Jan 11, 1994

TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY

K930810 · CIN

Chemistry · 328d

Cleared Jul 30, 1992

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO

K921745 · JFH

Chemistry · 108d

Cleared Jul 17, 1992

TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET

K920556 · JJX

Chemistry · 162d

Cleared Jul 17, 1992

TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

K921252 · JJX

Chemistry · 123d

Cleared Jun 09, 1992

TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY

K921763 · JHY

Chemistry · 56d

Cleared Aug 28, 1991

TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET

K912439 · JJX

Chemistry · 86d

Cleared Oct 31, 1989

TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT

K895094 · CEP

Chemistry · 78d

Cleared Sep 13, 1989

TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT

K894761 · CGJ

Chemistry · 48d

Cleared Dec 02, 1988

TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY

K884085 · JHY

Chemistry · 66d

Cleared Aug 25, 1987

TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY

K872131 · CEP

Chemistry · 82d