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Hybritech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
63
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYSeptember 11, 1997
K961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYAugust 19, 1996
K930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYJanuary 11, 1994
K922754TANDEM-E IGE II CALIBRATION VERIFICATION SETFebruary 17, 1993
K921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOJuly 30, 1992
K921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROLJuly 17, 1992
K920556TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SETJuly 17, 1992
K921763TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAYJune 9, 1992
K912439TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SETAugust 28, 1991
K911417ICON STREP B IMMUNOENZYMETRIC ASSAYJuly 24, 1991
K902991ICON STREP B IMMUNOENZYMETRIC ASSAYOctober 3, 1990
K895094TANDEM-E LH IMMUNOENZYMETRIC ASSAY KITOctober 31, 1989
K894761TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KITSeptember 13, 1989
K884085TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAYDecember 2, 1988
K872131TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAYAugust 25, 1987
K872063TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB IIJune 19, 1987
K871235TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KITJune 3, 1987
K870521TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAYApril 8, 1987
K865057TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAYMarch 10, 1987
K870520TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAYMarch 10, 1987