Medical Device Manufacturer · US , Mchenry , IL

Hybritech, Inc.

63 submissions · 63 cleared · Since 1981
63
Total
63
Cleared
0
Denied

Hybritech, Inc. — FDA 510(k) Submissions

Hybritech, Inc. has submitted 63 FDA 510(k) premarket notifications since 1981, of which 63 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Visual, Pregnancy Hcg, Prescription Use, Colorimetric Method, Cpk Or Isoenzymes, Radioimmunoassay, Prolactin (lactogen), Radioimmunoassay, Thyroid-stimulating Hormone, Single (specified) Analyte Controls (assayed And Unassayed) . Use the specialty filter in the sidebar to narrow results.

63 devices
1–25 of 63
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666 · CIN Electrophoretic... · Chemistry
Sep 1997 57d
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K961573 · CIN Electrophoretic... · Chemistry
Aug 1996 118d
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K930810 · CIN Electrophoretic... · Chemistry
Jan 1994 328d
TANDEM-E IGE II CALIBRATION VERIFICATION SET
K922754 · JJX Single (specified)... · Immunology
Feb 1993 254d
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
K921745 · JFH Acid Phosphatase... · Chemistry
Jul 1992 108d
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
K920556 · JJX Single (specified)... · Chemistry
Jul 1992 162d
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
K921252 · JJX Single (specified)... · Chemistry
Jul 1992 123d
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K921763 · JHY Colorimetric Method, Cpk... · Chemistry
Jun 1992 56d
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
K912439 · JJX Single (specified)... · Chemistry
Aug 1991 86d
ICON STREP B IMMUNOENZYMETRIC ASSAY
K911417 · GTZ Antisera, All Groups,... · Microbiology
Jul 1991 114d
ICON STREP B IMMUNOENZYMETRIC ASSAY
K902991 · GTY Antigens, All Groups,... · Microbiology
Oct 1990 86d
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
K895094 · CEP Radioimmunoassay,... · Chemistry
Oct 1989 78d
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
K894761 · CGJ Radioimmunoassay,... · Chemistry
Sep 1989 48d
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K884085 · JHY Colorimetric Method, Cpk... · Chemistry
Dec 1988 66d
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
K872131 · CEP Radioimmunoassay,... · Chemistry
Aug 1987 82d
TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II
K872063 · JHY Colorimetric Method, Cpk... · Chemistry
Jun 1987 22d
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
K871235 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jun 1987 68d
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
K870521 · JHI Visual, Pregnancy Hcg,... · Chemistry
Apr 1987 61d
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
K865057 · JHI Visual, Pregnancy Hcg,... · Chemistry
Mar 1987 76d
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520 · CGJ Radioimmunoassay,... · Chemistry
Mar 1987 32d
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
K864945 · JFH Acid Phosphatase... · Chemistry
Jan 1987 19d
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · LCX Kit, Test, Pregnancy,... · Chemistry
Dec 1986 82d
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM
K863859 · JLW Radioimmunoassay,... · Chemistry
Nov 1986 49d
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN
K863860 · CFT Radioimmunoassay,... · Chemistry
Nov 1986 49d
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
K863861 · JHI Visual, Pregnancy Hcg,... · Chemistry
Nov 1986 49d
Filters