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
1969–1992 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 15, 2008
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
K080662 · NDY
Genzyme Corporation
Chemistry · 66d
Cleared May 12, 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · JIX
Roche Diagnostics Corp.
Chemistry · 69d
Cleared May 08, 2008
TC MATRIX CLINICAL CHEMISTRY ANALYZER
K073370 · JJE
Teco Diagnostics
Chemistry · 160d
Cleared May 07, 2008
ESA BIOSCIENCES INC. VITAMIN D HPLC TEST
K072536 · MRG
Esa Biosciences, Inc.
Chemistry · 243d
Cleared May 07, 2008
PROLYTE ELECTROLYTE ANALYZER
K070104 · JGS
Diamond Diagnostics, Inc.
Chemistry · 483d
Cleared Apr 24, 2008
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
K073640 · LPS
Axis-Shield Diagnostics, Ltd.
Chemistry · 120d
Cleared Apr 21, 2008
SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
K080501 · NBW
Taidoc Technology Corporation
Chemistry · 56d
Cleared Apr 18, 2008
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
K073231 · NBW
Lifescan, Inc.
Chemistry · 155d
Cleared Apr 18, 2008
3TEST SUPREME GLUCOSE MONITORING SYSTEM
K072905 · NBW
Neuero Engineering, Inc.
Chemistry · 190d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · LCP
Roche Diagnostics Corp.
Chemistry · 206d
Cleared Apr 18, 2008
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
K072548 · CGS
Teco Diagnostics
Chemistry · 221d
Cleared Apr 14, 2008
HDL CHOLESTEROL REAGENT, MODEL 10211
K073497 · LBS
Medica Corp.
Chemistry · 123d
Cleared Apr 14, 2008
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
K070889 · CGZ
Wallac OY
Chemistry · 381d
Cleared Apr 10, 2008
GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
K073648 · CGA
Apex BioTechnology Corp.
Chemistry · 106d
Cleared Apr 10, 2008
GBI TSH NEONATAL SCREENING KIT
K072458 · JLW
Golden Bridge International, Inc.
Chemistry · 223d
Cleared Apr 08, 2008
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD...
K073492 · NBW
Tyson Bioresearch, Inc.
Chemistry · 118d
Cleared Apr 04, 2008
ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300
K063437 · JLW
Monobind, Inc.
Chemistry · 507d
Cleared Apr 02, 2008
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND...
K073494 · NBW
Taidoc Technology Corporation
Chemistry · 112d
Cleared Apr 01, 2008
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
K073137 · NBW
Apex BioTechnology Corp.
Chemistry · 146d
Cleared Mar 26, 2008
MCT-DIABETES
K073699 · NBW
Mycare Team, Inc.
Chemistry · 86d
Cleared Mar 25, 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET...
K080183 · DIF
Roche Diagnostics Corp.
Chemistry · 60d
Cleared Mar 25, 2008
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
K072441 · NBW
Tyson Bioresearch, Inc.
Chemistry · 208d
Cleared Mar 21, 2008
EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
K072369 · NBW
Hmd Biomedical, LLC
Chemistry · 211d
Cleared Mar 19, 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166 · JIT
Beckman Coulter, Inc.
Chemistry · 56d