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
6577–6600 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 10, 1991
SUPERSERUM REAGENT (SSR)
K910646 · JKA
International Technidyne Corp.
Chemistry · 86d
Cleared May 08, 1991
SYSTEMATE CREATININE (EPOS APPLICATION) #65413
K905658 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared May 08, 1991
IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
K911060 · KLS
Immunomatrix
Chemistry · 58d
Cleared May 08, 1991
HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER
K911141 · CGA
Hemocue, Inc.
Chemistry · 55d
Cleared May 06, 1991
BIOTROL PROTEIN MULTILEVEL STANDARDS
K910721 · JIS
Biotrol, USA, Inc.
Chemistry · 75d
Cleared May 06, 1991
CLEARBLUE EASY
K911566 · LCX
Unipath , Ltd.
Chemistry · 27d
Cleared May 01, 1991
CIBA CORNING ACS FT4 IMMUNOASSAY
K910684 · CEC
Ciba Corning Diagnostics Corp.
Chemistry · 71d
Cleared May 01, 1991
SRI T3 IMMOENZYMETRIC ASSAY
K910737 · CDP
Serono-Baker Diagnostics, Inc.
Chemistry · 69d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
K910930 · DIF
Analytical Control Systems, Inc.
Chemistry · 56d
Cleared Apr 30, 1991
AMYLASE
K910158 · JFJ
Pointe Scientific, Inc.,
Chemistry · 105d
Cleared Apr 30, 1991
CIBA CORNING ACS TSH IMMUNOASSAY
K910981 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 54d
Cleared Apr 29, 1991
J&S PEDIATRIC IRON SATURATING REAGENT
K910672 · JQE
J.S. Medical Assoc.
Chemistry · 73d
Cleared Apr 29, 1991
IMMULITE(TM) T-UPTAKE
K910677 · CEE
Cirrus Diagnostics, Inc.
Chemistry · 73d
Cleared Apr 29, 1991
CIBA CORNING ACS T UPTAKE IMMUNOASSAY
K911093 · KHQ
Ciba Corning Diagnostics Corp.
Chemistry · 48d
Cleared Apr 24, 1991
ROCHE REAGENT FOR TOTAL BILIRUBIN
K910591 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Apr 24, 1991
ROCHE REAGENT FOR DIRECT BILIRUBIN
K910593 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Apr 18, 1991
DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER
K904783 · JJQ
Industrial Chemical Measurement
Chemistry · 178d
Cleared Apr 16, 1991
CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL
K905457 · DIF
Consolidated Technologies, Inc.
Chemistry · 132d
Cleared Apr 16, 1991
IMMULITE(TM) TOTAL T4
K910261 · KLI
Cirrus Diagnostics, Inc.
Chemistry · 84d
Cleared Apr 16, 1991
CHLORIDE REAGENT
K911297 · CHJ
Intersect Systems, Inc.
Chemistry · 22d
Cleared Apr 16, 1991
REP SPE PLUS (ACID BLUE) SYSTEM
K911468 · CEF
Helena Laboratories
Chemistry · 13d
Cleared Apr 12, 1991
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
K904752 · JIR
Boehringer Mannheim Corp.
Chemistry · 175d
Cleared Apr 12, 1991
CHALLENGE (TM) LIQ THERA DRUG CONTROLS
K910333 · DIF
Medical Analysis Systems, Inc.
Chemistry · 77d
Cleared Apr 12, 1991
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
K910633 · CGA
Yellow Springs Instrument Co., Inc.
Chemistry · 58d