Hybritech, Inc. - FDA 510(k) Cleared Devices
63
Total
63
Cleared
0
Denied
63 devices
Cleared
Nov 03, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--
Immunology
31d
Cleared
Oct 08, 1986
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
Immunology
40d
Cleared
Aug 19, 1986
ICON READER
Chemistry
14d
Cleared
Aug 15, 1986
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
Immunology
32d
Cleared
Apr 29, 1986
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
Chemistry
43d
Cleared
Apr 04, 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
Microbiology
32d
Cleared
Mar 05, 1986
ENCORE PROLACTIN REAGENT
Chemistry
42d
Cleared
Mar 05, 1986
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
Chemistry
21d
Cleared
Jan 01, 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
Microbiology
163d
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
Oct 01, 1984
ENCORE IGE REAGENT
Immunology
31d
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