Hybritech, Inc. - FDA 510(k) Cleared Devices
63
Total
63
Cleared
0
Denied
63 devices
Cleared
Aug 12, 1983
TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY
Chemistry
46d
Cleared
Feb 25, 1983
TANDEM-E -FER IMMUNOENZYMETRIC KIT
Chemistry
64d
Cleared
Feb 07, 1983
TANDEM E GCG VISUAL END POINT INNUMOENZ
Chemistry
25d
Cleared
Dec 28, 1982
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
Chemistry
34d
Cleared
Oct 13, 1982
TAMDEM-R THYROID STIMULATING HORMONE KIT
Chemistry
36d
Cleared
Jul 22, 1982
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT
Chemistry
23d
Cleared
Jun 11, 1982
TANDEM PROLACTIN KIT
Chemistry
17d
Cleared
Jun 10, 1982
TANDEM - HGH KIT
Chemistry
31d
Cleared
Apr 29, 1982
TANDEM HCG KIT
Chemistry
36d
Cleared
Oct 19, 1981
FERRITIN KIT
Immunology
35d
Cleared
Oct 13, 1981
TANDEM QUALITATIVE HCG KIT
Chemistry
43d
Cleared
Sep 01, 1981
TANDEM PAP KIT - (PARTS I & II)
Chemistry
54d
Cleared
May 29, 1981
TAN DEM* - IGE KIT
Chemistry
192d