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
1129–1152 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 26, 2013
EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
K131595 · JJY
Eurotrol B.V.
Chemistry · 53d
Cleared Jul 18, 2013
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
K131776 · JJX
Randox Laboratories, Ltd.
Chemistry · 31d
Cleared Jul 17, 2013
COBAS C BILIRUBIN TOTAL GEN.3
K131544 · CIG
Roche Diagnostics
Chemistry · 49d
Cleared Jul 17, 2013
25-OH VITAMIN D ELISA
K123660 · MRG
Euroimmun US
Chemistry · 231d
Cleared Jul 15, 2013
LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
K130657 · NBW
All Medicus Co., Ltd.
Chemistry · 125d
Cleared Jul 15, 2013
25OH VITAMIN D TOTAL ELISA TEST
K123364 · MRG
Diasource Immunoassays, S.A.
Chemistry · 256d
Cleared Jul 03, 2013
FASTPACK VITAMIN D
K123983 · MRG
Qualigen, Inc.
Chemistry · 189d
Cleared Jul 03, 2013
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL,...
K123171 · CJY
HORIBA ABX SAS
Chemistry · 267d
Cleared Jun 28, 2013
SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
K123559 · NBW
Biotest Medical Corp.
Chemistry · 221d
Cleared Jun 27, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K130094 · NBW
Abbott Diabetes Care
Chemistry · 168d
Cleared Jun 26, 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
K131556 · JIT
Diazyme Laboratories
Chemistry · 28d
Cleared Jun 21, 2013
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL...
K130295 · NBW
Infopia Co, Ltd.
Chemistry · 135d
Cleared Jun 20, 2013
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
K121101 · JIA
Astoria-Pacific, Inc.
Chemistry · 435d
Cleared Jun 19, 2013
VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD...
K123007 · NBW
Mico Biomed Co., Ltd.
Chemistry · 265d
Cleared Jun 18, 2013
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL...
K123253 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 244d
Cleared Jun 18, 2013
TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800...
K123087 · NBW
Tyson Bioresearch, Inc.
Chemistry · 260d
Cleared Jun 18, 2013
VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS
K123016 · NBW
Mico Biomed Co., Ltd.
Chemistry · 264d
Cleared Jun 14, 2013
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE...
K121214 · MMI
Beckman Coulter, Inc.
Chemistry · 417d
Cleared Jun 07, 2013
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
K131217 · CIG
Hitachi Chemical Diagnostics, Inc.
Chemistry · 38d
Cleared Jun 07, 2013
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
K131051 · JGQ
Hitachi Chemical Diagnostics, Inc.
Chemistry · 53d
Cleared Jun 07, 2013
DIAZYME MYOGLOBIN
K123785 · DDR
Diazyme Laboratories
Chemistry · 179d
Cleared Jun 07, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL...
K120945 · CKA
Hitachi Chemical Diagnostics, Inc.
Chemistry · 435d
Cleared May 31, 2013
GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
K131136 · JJX
Bionostics, Inc.
Chemistry · 39d
Cleared May 31, 2013
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
K130332 · CDT
Ortho-Clinical Diagnostics, Inc.
Chemistry · 109d