FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
7921–7944 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 18, 1988
DEXPAD, BLOOD GLUCOSE STRIP
K880585 · CGA
Mach Diag. C/O Wichita State University
Chemistry · 68d
Cleared Apr 18, 1988
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO
K880619 · KHQ
Syva Co.
Chemistry · 62d
Cleared Apr 18, 1988
LABCO LIMITED EXETAINER(R)
K880622 · JKA
Labco, Ltd.
Chemistry · 62d
Cleared Apr 18, 1988
SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
K880758 · CEP
Boots-Celltech Diagnostics, Inc.
Chemistry · 53d
Cleared Apr 18, 1988
RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL
K880794 · KHS
Trace America, Inc.
Chemistry · 52d
Cleared Apr 18, 1988
RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.
K880795 · CJE
Trace America, Inc.
Chemistry · 52d
Cleared Apr 18, 1988
ALKALINE PHOSPHATASE REAGENT, DEA BUFF
K880796 · CJE
Trace America, Inc.
Chemistry · 52d
Cleared Apr 18, 1988
ACID PHOSPHATASE REAGENT
K880798 · CKB
Trace America, Inc.
Chemistry · 52d
Cleared Apr 18, 1988
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
K880934 · JLS
Amersham Corp.
Chemistry · 42d
Cleared Apr 18, 1988
CALCIUM, CATALOGUE NUMBER 122-20
K881054 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 38d
Cleared Apr 18, 1988
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
K881124 · CEP
Nichols Institute Diagnostics
Chemistry · 33d
Cleared Apr 13, 1988
ROMEO(TM) MODEL 1000
K872889 · CGA
Diva Medical Systems, Inc.
Chemistry · 265d
Cleared Apr 05, 1988
GLYCO-PROBE GSP
K873428 · LCP
Isolab, Inc.
Chemistry · 224d
Cleared Apr 05, 1988
FIRST RESPONSE 5 MINUTE PREGNANCY TEST
K874823 · LCX
Tambrands, Inc.
Chemistry · 133d
Cleared Apr 05, 1988
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
K875079 · CKA
Miles Laboratories, Inc.
Chemistry · 118d
Cleared Apr 05, 1988
ABBOTT IMX HTSH
K880086 · JLW
Abbott Laboratories
Chemistry · 84d
Cleared Apr 05, 1988
ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
K880177 · CIO
Tech-Co, Inc.
Chemistry · 81d
Cleared Apr 05, 1988
HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT
K880410 · JHI
Disease Detection International, Inc.
Chemistry · 64d
Cleared Apr 05, 1988
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY
K880678 · DHA
Ventrex Laboratories, Inc.
Chemistry · 46d
Cleared Apr 05, 1988
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
K880743 · CIG
Abbott Laboratories
Chemistry · 41d
Cleared Apr 05, 1988
LDH-L REAGENT SET
K880842 · CFJ
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
CREATININE REAGENT SET (KINETIC)
K880843 · CGX
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
ALBUMIN REAGENT SET
K880844 · CIX
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
CALCIUM REAGENT SET
K880845 · CIC
Tech-Neal Scientific, Inc.
Chemistry · 39d