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
2281–2304 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 16, 2006
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA...
K060325 · CIG
Horiba Abx
Chemistry · 188d
Cleared Aug 14, 2006
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
K061885 · JIT
Dade Behring, Inc.
Chemistry · 42d
Cleared Aug 11, 2006
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
K061750 · JIX
Dade Behring, Inc.
Chemistry · 51d
Cleared Aug 11, 2006
ACON URINALYSIS REAGENT STRIPS
K061559 · CDM
Acon Laboratories Co.
Chemistry · 67d
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