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

Filters: Chemistry ×
13,257 results
1321–1344 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared May 10, 2012
ELECSYS LH CALCHECK 5
K121279 · JJX
Roche Diagnostics
Chemistry · 10d
Cleared May 10, 2012
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
K120369 · CFR
Hitachi Chemical Diagnostics, Inc.
Chemistry · 94d
Cleared May 10, 2012
COMPLETE D 25-OH VITAMIN D CONTROL
K113177 · JJX
Quantimetrix Corp.
Chemistry · 195d
Cleared May 09, 2012
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
K121084 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d