Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

63 results for "Hybritech, Inc."
1–24 of 63
Search insights Median review: 48d Cleared: 100% Top manufacturer: Hybritech, Inc. Lead specialty: Chemistry
Cleared Sep 11, 1997
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666 · CIN
Hybritech, Inc.
Chemistry · 57d
Cleared Aug 19, 1996
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K961573 · CIN
Hybritech, Inc.
Chemistry · 118d
Cleared Jan 11, 1994
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K930810 · CIN
Hybritech, Inc.
Chemistry · 328d
Cleared Feb 17, 1993
TANDEM-E IGE II CALIBRATION VERIFICATION SET
K922754 · JJX
Hybritech, Inc.
Immunology · 254d
Cleared Jul 30, 1992
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
K921745 · JFH
Hybritech, Inc.
Chemistry · 108d
Cleared Jul 17, 1992
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
K921252 · JJX
Hybritech, Inc.
Chemistry · 123d
Cleared Jul 17, 1992
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
K920556 · JJX
Hybritech, Inc.
Chemistry · 162d
Cleared Jun 09, 1992
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K921763 · JHY
Hybritech, Inc.
Chemistry · 56d
Cleared Aug 28, 1991
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
K912439 · JJX
Hybritech, Inc.
Chemistry · 86d
Cleared Jul 24, 1991
ICON STREP B IMMUNOENZYMETRIC ASSAY
K911417 · GTZ
Hybritech, Inc.
Microbiology · 114d
Cleared Oct 03, 1990
ICON STREP B IMMUNOENZYMETRIC ASSAY
K902991 · GTY
Hybritech, Inc.
Microbiology · 86d
Cleared Oct 31, 1989
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
K895094 · CEP
Hybritech, Inc.
Chemistry · 78d
Cleared Sep 13, 1989
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
K894761 · CGJ
Hybritech, Inc.
Chemistry · 48d
Cleared Dec 02, 1988
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K884085 · JHY
Hybritech, Inc.
Chemistry · 66d
Cleared Aug 25, 1987
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
K872131 · CEP
Hybritech, Inc.
Chemistry · 82d
Cleared Jun 19, 1987
TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II
K872063 · JHY
Hybritech, Inc.
Chemistry · 22d
Cleared Jun 03, 1987
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
K871235 · JHI
Hybritech, Inc.
Chemistry · 68d
Cleared Apr 08, 1987
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
K870521 · JHI
Hybritech, Inc.
Chemistry · 61d
Cleared Mar 10, 1987
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520 · CGJ
Hybritech, Inc.
Chemistry · 32d
Cleared Mar 10, 1987
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
K865057 · JHI
Hybritech, Inc.
Chemistry · 76d
Cleared Jan 05, 1987
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
K864945 · JFH
Hybritech, Inc.
Chemistry · 19d
Cleared Dec 22, 1986
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · LCX
Hybritech, Inc.
Chemistry · 82d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
K863861 · JHI
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN
K863860 · CFT
Hybritech, Inc.
Chemistry · 49d