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
1297–1320 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 03, 2012
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
K121122 · DIF
Biochemical Diagnostic, Inc.
Chemistry · 81d
Cleared Jul 03, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C,...
K113262 · CHH
Alfa Wassermann Diagnostic...
Chemistry · 242d
Cleared Jul 02, 2012
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL...
K113435 · KHS
Alfa Wassermann
Chemistry · 224d
Cleared Jun 28, 2012
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
K121087 · NBW
Bayer Healthcare
Chemistry · 79d
Cleared Jun 22, 2012
EUROTROL GAS-ISE METABOLITES
K121468 · JJY
Eurotrol B.V.
Chemistry · 36d
Cleared Jun 21, 2012
EASYDEX
K120247 · MRV
Vineland Syrup, Inc.
Chemistry · 146d
Cleared Jun 20, 2012
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
K121588 · JJX
Randox Laboratories, Ltd.
Chemistry · 20d
Cleared Jun 20, 2012
CONE-TROL HEMOGLOBIN A1C CONTROL SET
K121534 · JJX
Cone Bioproducts
Chemistry · 27d
Cleared Jun 15, 2012
ST AIA-PACK HOMOCYSTEINE
K121533 · LPS
Tosoh Bioscience, Inc.
Chemistry · 22d
Cleared Jun 15, 2012
AUDIT MICROLQ SPINAL FLUID CONTROL
K112742 · JJY
Aalto Scientific, Ltd.
Chemistry · 268d
Cleared Jun 05, 2012
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER,...
K120759 · CGA
I-Sens, Inc.
Chemistry · 84d
Cleared Jun 05, 2012
HOMOCYSTEINE TEST
K113793 · LPS
Roche
Chemistry · 165d
Cleared Jun 01, 2012
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT,...
K113438 · JMO
Alfa Wassermann Diagnostic...
Chemistry · 193d
Cleared May 25, 2012
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD...
K110074 · NBW
Health & Life Co., Ltd.
Chemistry · 501d
Cleared May 22, 2012
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE...
K120042 · LFR
Taidoc Technology Corporation
Chemistry · 138d
Cleared May 18, 2012
BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3...
K121237 · JJX
Cliniqa Corporation
Chemistry · 24d
Cleared May 18, 2012
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF...
K121207 · LFR
Eps Bio Technology Corp.
Chemistry · 28d
Cleared May 18, 2012
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
K121143 · DIF
Bio-Rad Laboratories
Chemistry · 32d
Cleared May 17, 2012
ARCHITECT B12
K121314 · CDD
Abbott Laboratories
Chemistry · 15d
Cleared May 17, 2012
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN...
K113253 · JJE
Alfa Wassermann Diagnostic...
Chemistry · 197d
Cleared May 15, 2012
ADVIA CHEMISTRY GLUH_3 REAGENTS
K120681 · CFR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 70d
Cleared May 14, 2012
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
K120497 · LCP
Medica Corp.
Chemistry · 83d
Cleared May 14, 2012
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123...
K111188 · CHL
Roche Diagnostics
Chemistry · 383d
Cleared May 11, 2012
ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
K120183 · NBW
Broadmaster Biotech Corperation
Chemistry · 109d