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."
25–48 of 63
Search insights Median review: 48d Cleared: 100% Top manufacturer: Hybritech, Inc. Lead specialty: Chemistry
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM
K863859 · JLW
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 03, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--
K863858 · DGC
Hybritech, Inc.
Immunology · 31d
Cleared Oct 08, 1986
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
K863345 · DBF
Hybritech, Inc.
Immunology · 40d
Cleared Aug 19, 1986
ICON READER
K862956 · JQT
Hybritech, Inc.
Chemistry · 14d
Cleared Aug 15, 1986
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
K862674 · JZT
Hybritech, Inc.
Immunology · 32d
Cleared Apr 29, 1986
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K860984 · CEP
Hybritech, Inc.
Chemistry · 43d
Cleared Apr 04, 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778 · GTZ
Hybritech, Inc.
Microbiology · 32d
Cleared Mar 05, 1986
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
K860542 · JHI
Hybritech, Inc.
Chemistry · 21d
Cleared Mar 05, 1986
ENCORE PROLACTIN REAGENT
K860221 · CFT
Hybritech, Inc.
Chemistry · 42d
Cleared Jan 01, 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
K853069 · LFX
Hybritech, Inc.
Microbiology · 163d
Cleared Jul 12, 1985
HYBRITECH IMMUNOCHEMISTRY ANALYZER
K852385 · JJF
Hybritech, Inc.
Chemistry · 37d
Cleared Jun 25, 1985
TANDEM E PAP
K851950 · JFH
Hybritech, Inc.
Chemistry · 53d
Cleared Mar 21, 1985
ENCORE FERRITIN REAGENT
K850680 · JMB
Hybritech, Inc.
Chemistry · 28d
Cleared Mar 04, 1985
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
K850159 · JHI
Hybritech, Inc.
Chemistry · 48d
Cleared Jan 18, 1985
BAKER CKMB REAGENT SET
K845024 · JHY
Hybritech, Inc.
Chemistry · 22d
Cleared Nov 13, 1984
TANDEM - EPRL
K843804 · CFT
Hybritech, Inc.
Chemistry · 47d
Cleared Oct 11, 1984
ENCORE TSH REAGENT
K843395 · JLW
Hybritech, Inc.
Chemistry · 43d
Cleared Oct 04, 1984
ENCORE HCG REAGENT
K843407 · JHI
Hybritech, Inc.
Chemistry · 34d
Cleared Oct 01, 1984
ENCORE IGE REAGENT
K843408 · DGC
Hybritech, Inc.
Immunology · 31d
Cleared Aug 23, 1984
TANDEM FAST VISUAL HCG ASSAY KIT -
K842633 · JHI
Hybritech, Inc.
Chemistry · 45d
Cleared Feb 21, 1984
HYBRITECH DATA STATION
K834300 · JQP
Hybritech, Inc.
Chemistry · 74d
Cleared Feb 03, 1984
TANDEM VISUAL HCG IMMUNOENZYMETRIC
K834000 · JHI
Hybritech, Inc.
Chemistry · 74d
Cleared Jan 18, 1984
TANDEM R-TOTAL B-GCG KIT
K833194 · JHI
Hybritech, Inc.
Chemistry · 121d
Cleared Oct 31, 1983
TANDEM-E THYROID STIMULATING HORMONE KIT
K832813 · JLW
Hybritech, Inc.
Chemistry · 73d