FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
1105–1128 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 26, 2013
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
K131931 · LCX
Chemtron Biotech, Inc.
Chemistry · 29d
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