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
2305–2328 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620 · NBW
Roche Diagnostics Corp.
Chemistry · 156d
Cleared Aug 08, 2006
DPC T60I KUSTI, MODEL 984248
K061107 · CEM
Thermo Electron OY
Chemistry · 110d
Cleared Aug 08, 2006
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060318 · CIT
Horiba Abx
Chemistry · 181d
Cleared Aug 07, 2006
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
K062055 · JIX
Dade Behring, Inc.
Chemistry · 18d
Cleared Aug 07, 2006
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061793 · JIY
Dade Behring, Inc.
Chemistry · 42d
Cleared Aug 04, 2006
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
K061730 · CEM
Osmetech, Inc.
Chemistry · 45d
Cleared Aug 02, 2006
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
K061703 · JIX
Dade Behring, Inc.
Chemistry · 47d
Cleared Jul 28, 2006
ACTIVE RENIN IRMA
K061758 · CIB
Diagnostic Systems Laboratories, Inc.
Chemistry · 36d
Cleared Jul 25, 2006
ELEMENT BLOOD GLUCOSE TEST SYSTEM
K060793 · NBW
Home Diagnostics, Inc.
Chemistry · 124d
Cleared Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683 · DDR
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Jul 21, 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K061588 · LPS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 43d
Cleared Jul 21, 2006
QMS TOBRAMYCIN
K060998 · LCR
Seradyn, Inc.
Chemistry · 101d
Cleared Jul 21, 2006
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
K060619 · KHS
Diazyme Laboratories
Chemistry · 135d
Cleared Jul 21, 2006
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060205 · CJE
Horiba Abx
Chemistry · 176d
Cleared Jul 21, 2006
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
K053597 · NBC
I-Stat Corporation
Chemistry · 210d
Cleared Jul 18, 2006
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
K061818 · JIT
Dade Behring, Inc.
Chemistry · 20d
Cleared Jul 18, 2006
DAVID PREGNANCY TEST (MIDSTREAM)
K053236 · LCX
Runbio Biotech Co.,Ltd
Chemistry · 242d
Cleared Jul 13, 2006
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
K061751 · JIT
Dade Behring, Inc.
Chemistry · 22d
Cleared Jul 13, 2006
PRODIGY BLOOD GLUCOSE TEST SYSTEM
K060467 · NBW
Diagnostic Devices, Inc.
Chemistry · 140d
Cleared Jul 10, 2006
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
K061702 · JIT
Dade Behring, Inc.
Chemistry · 24d
Cleared Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · LDP
Dade Behring, Inc.
Chemistry · 27d
Cleared Jul 10, 2006
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788 · DIF
Biosite Incorporated
Chemistry · 109d
Cleared Jul 06, 2006
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
K061181 · NBW
Taidoc Technology Corporation
Chemistry · 70d
Cleared Jul 06, 2006
PRODIGY
K053593 · NBW
Diagnostic Devices, Inc.
Chemistry · 195d