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
1609–1632 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 18, 2010
MEDTOX BUPRENORPHINE TEST
K100951 · DJG
Medtox Diagnostics, Inc.
Chemistry · 195d
Cleared Sep 28, 2010
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL,...
K100550 · LBS
Polymedco, Inc.
Chemistry · 214d
Cleared Sep 28, 2010
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
K093137 · NDY
Kamiya Biomedical Co.
Chemistry · 358d
Cleared Sep 24, 2010
FDI GLUCOSE CONTROL SOLUTIONS
K102260 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 45d
Cleared Sep 20, 2010
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL...
K093883 · CIT
Seppim S.A.S.
Chemistry · 276d
Cleared Sep 14, 2010
LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED...
K100727 · JJY
Bio-Rad, Diagnostics Grp.
Chemistry · 183d
Cleared Sep 14, 2010
ST AIA-PACK CYSTATIN C, MODEL 025217
K093960 · NDY
Tosoh Bioscience, Inc.
Chemistry · 265d
Cleared Sep 10, 2010
ELECSYS FERRITIN CALCHECK 5
K102267 · JJX
Roche Diagnostics
Chemistry · 32d
Cleared Sep 10, 2010
TINA-QUANT ALBUMIN GEN 2
K101203 · DCF
Roche Diagnostics
Chemistry · 134d
Cleared Sep 09, 2010
COBAS 8000 MODULAR SERIES ANALYZER
K100853 · DCF
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Sep 08, 2010
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS...
K101456 · JIX
Roche Diagnostics
Chemistry · 105d
Cleared Sep 03, 2010
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
K100718 · JJY
Aalto Scientific, Ltd.
Chemistry · 175d
Cleared Sep 02, 2010
NIOX MINO MODEL 09-1000
K101034 · MXA
Aerocrine AB
Chemistry · 141d
Cleared Sep 01, 2010
PRECICONTROL CLINCHEM MULTI 1 AND 2
K102016 · JJY
Roche Diagnostics
Chemistry · 44d
Cleared Aug 31, 2010
ELECSYS DIGOXIN CALCHECK 5
K102044 · JJX
Roche Diagnostics
Chemistry · 41d
Cleared Aug 31, 2010
GELSCAN, MODEL 1206
K100307 · CFE
Sebia
Chemistry · 209d
Cleared Aug 27, 2010
ELECSYS PRECICONTROL MULTIMARKER
K102157 · JJY
Roche Diagnostics
Chemistry · 28d
Cleared Aug 27, 2010
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
K101633 · JJY
Nova Biomedical Corp.
Chemistry · 78d
Cleared Aug 27, 2010
ST AIA PACK HBA1C
K100304 · LCP
Tosoh Bioscience, Inc.
Chemistry · 205d
Cleared Aug 26, 2010
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE...
K093420 · NTI
Luminex Molecular Diagnostics, Inc.
Chemistry · 296d
Cleared Aug 25, 2010
RAPIDVUE HCG TEST
K102175 · JHI
Quidel Corporation
Chemistry · 23d
Cleared Aug 23, 2010
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
K093916 · NQL
Perkinelmer, Inc.
Chemistry · 244d
Cleared Aug 13, 2010
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
K102037 · CGA
Apex BioTechnology Corp.
Chemistry · 25d
Cleared Aug 13, 2010
FASTPACK TSH IMMUNOASSAY
K101390 · JLW
Qualigen, Inc.
Chemistry · 88d