Medical Device Manufacturer · US , Mchenry , IL

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

63 submissions · 63 cleared · Since 1981

63

Total

63

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hybritech, Inc. Microbiology ✕

4 devices

1-4 of 4

Cleared Jul 24, 1991

ICON STREP B IMMUNOENZYMETRIC ASSAY

Microbiology · 114d

Cleared Oct 03, 1990

ICON STREP B IMMUNOENZYMETRIC ASSAY

Microbiology · 86d

Cleared Apr 04, 1986

TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT

Microbiology · 32d

Cleared Jan 01, 1986

TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT

Microbiology · 163d