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
1633–1656 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Aug 13, 2010
ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
K092875 · NBW
Taidoc Technology Corporation
Chemistry · 329d
Cleared Aug 06, 2010
ABL90 FLEX SERIES
K092686 · CEM
Radiometer Medical Aps
Chemistry · 338d
Cleared Jul 29, 2010
FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION
K093724 · JJX
Taidoc Technology Corporation
Chemistry · 238d
Cleared Jul 28, 2010
AMPHETAMINES II ASSAY
K093664 · DKZ
Roche Diagnostics Corp.
Chemistry · 243d