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
2401–2424 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 16, 2006
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
K060108 · CGZ
Roche Diagnostics Corp.
Chemistry · 34d
Cleared Feb 16, 2006
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
K053108 · DLJ
Dade Behring, Inc.
Chemistry · 104d
Cleared Feb 15, 2006
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
K053566 · MZV
Diazyme Laboratories
Chemistry · 55d
Cleared Feb 09, 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA...
K053603 · NQD
Roche Diagnostics Corp.
Chemistry · 48d
Cleared Feb 09, 2006
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591 · DCK
Clinical Data, Inc.
Chemistry · 141d
Cleared Feb 07, 2006
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
K053576 · JIT
Dade Behring, Inc.
Chemistry · 47d
Cleared Feb 03, 2006
IMMULITE/IMMULITE 1000 TURBO INTACT PTH
K053533 · CEW
Diagnostic Products Corporation
Chemistry · 46d
Cleared Feb 03, 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · LCP
Microgenics Corp.
Chemistry · 58d
Cleared Jan 31, 2006
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
K051648 · CGS
Arkray, Inc.
Chemistry · 224d
Cleared Jan 27, 2006
DRG SLV TESTOSTERONE ELISA TEST
K052649 · CDZ
Drg Intl., Inc.
Chemistry · 123d
Cleared Jan 26, 2006
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
K060027 · JJX
Biokit, S.A.
Chemistry · 22d
Cleared Jan 26, 2006
OXICOM CONTROL
K053327 · JJX
Bionostics, Inc.
Chemistry · 56d
Cleared Jan 26, 2006
SENTINEL PANCREATIC AMYLASE
K051447 · JFJ
Sentinel Ch. Srl
Chemistry · 238d
Cleared Jan 23, 2006
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
K052789 · NBC
Biosite Incorporated
Chemistry · 112d
Cleared Jan 23, 2006
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
K052762 · NBW
Agamatrix, Inc.
Chemistry · 115d
Cleared Jan 23, 2006
LIFESIGN DXPRESS, MODEL LSR2000
K050955 · JHI
Princeton BioMeditech Corp.
Chemistry · 283d
Cleared Jan 20, 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 17d
Cleared Jan 17, 2006
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
K053529 · NBW
Lifescan, Inc.
Chemistry · 29d
Cleared Jan 13, 2006
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
K053247 · JJY
Maine Standards Co.
Chemistry · 53d
Cleared Jan 13, 2006
RANDOX CALIBRATION SERUM
K053153 · JIX
Randox Laboratories, Ltd.
Chemistry · 64d
Cleared Jan 13, 2006
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+...
K053110 · JGS
I-Stat Corporation
Chemistry · 70d
Cleared Jan 04, 2006
FASTPACK TSH IMMUNOASSAY
K052301 · JLW
Qualigen, Inc.
Chemistry · 135d
Cleared Dec 30, 2005
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
K053132 · JFM
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Dec 30, 2005
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131 · JFM
Wako Chemicals USA, Inc.
Chemistry · 52d