Hybritech, Inc. - FDA 510(k) Cleared Devices
63
Total
63
Cleared
0
Denied
53 devices
Cleared
Mar 05, 1986
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
Chemistry
21d
Cleared
Jul 12, 1985
HYBRITECH IMMUNOCHEMISTRY ANALYZER
Chemistry
37d
Cleared
Jun 25, 1985
TANDEM E PAP
Chemistry
53d
Cleared
Mar 21, 1985
ENCORE FERRITIN REAGENT
Chemistry
28d
Cleared
Mar 04, 1985
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
Chemistry
48d
Cleared
Jan 18, 1985
BAKER CKMB REAGENT SET
Chemistry
22d
Cleared
Nov 13, 1984
TANDEM - EPRL
Chemistry
47d
Cleared
Oct 11, 1984
ENCORE TSH REAGENT
Chemistry
43d
Cleared
Oct 04, 1984
ENCORE HCG REAGENT
Chemistry
34d
Cleared
Aug 23, 1984
TANDEM FAST VISUAL HCG ASSAY KIT -
Chemistry
45d
Cleared
Feb 21, 1984
HYBRITECH DATA STATION
Chemistry
74d
Cleared
Feb 03, 1984
TANDEM VISUAL HCG IMMUNOENZYMETRIC
Chemistry
74d
Cleared
Jan 18, 1984
TANDEM R-TOTAL B-GCG KIT
Chemistry
121d
Cleared
Oct 31, 1983
TANDEM-E THYROID STIMULATING HORMONE KIT
Chemistry
73d
Cleared
Aug 31, 1983
HYBRITECH 405-500 NM FILTER MODULE
Chemistry
42d
Cleared
Aug 26, 1983
PHOTON IMMUNOASSAY ANALYZER
Chemistry
39d
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