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
3649–3672 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 07, 2000
ELECSYS CORTISOL TEST SYSTEM
K000270 · JJY
Roche Diagnostics Corp.
Chemistry · 39d
Cleared Mar 02, 2000
UBAS
K993941 · KWX
Marukin Diagnostics
Chemistry · 104d
Cleared Mar 02, 2000
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
K000231 · JJX
Biosite Incorporated
Chemistry · 35d
Cleared Feb 29, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS
K000230 · JJX
Biosite Incorporated
Chemistry · 33d
Cleared Feb 28, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT...
K000318 · JJX
Bionostics, Inc.
Chemistry · 27d
Cleared Feb 24, 2000
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
K000056 · JJX
Biocell Laboratories, Inc.
Chemistry · 48d
Cleared Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
K000365 · CGA
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Feb 23, 2000
ACCU-CHEK COMPLETE METER
K000364 · LFR
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Feb 18, 2000
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315,...
K000196 · DDR
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Feb 18, 2000
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · CGX
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Feb 15, 2000
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K992662 · MSJ
Bayer Corp.
Chemistry · 190d
Cleared Feb 15, 2000
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
K000116 · JJY
Consolidated Technologies, Inc.
Chemistry · 32d
Not Cleared Feb 15, 2000
WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000
DEN990008 · NAK
Wallac, Inc.
Chemistry · 57d
Cleared Feb 10, 2000
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
K000331 · JIS
Beckman Coulter, Inc.
Chemistry · 50d
Cleared Feb 08, 2000
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · CFR
Teco Diagnostics
Chemistry · 26d
Cleared Feb 04, 2000
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K994438 · MQM
Spectrx, Inc.
Chemistry · 36d
Cleared Feb 03, 2000
ADVANTAGE HCG TEST (URINE/SERUM)
K994227 · JHI
Advantage Diagnostics Corp.
Chemistry · 50d
Cleared Feb 03, 2000
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
K994169 · JIS
Beckman Coulter, Inc.
Chemistry · 55d
Cleared Feb 03, 2000
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
K994168 · JIS
Beckman Coulter, Inc.
Chemistry · 55d
Cleared Feb 01, 2000
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
K994346 · CHL
Sendx Medical, Inc.
Chemistry · 40d
Cleared Feb 01, 2000
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
K994035 · JIR
Diagnostic Chemicals , Ltd.
Chemistry · 64d
Cleared Jan 28, 2000
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · JMO
Dade Behring, Inc.
Chemistry · 53d
Cleared Jan 28, 2000
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
K994085 · DHA
Diagnostic Products Corp.
Chemistry · 56d
Cleared Jan 27, 2000
GAMBRO DQM 200
K990039 · LFP
Gambro Healthcare
Chemistry · 386d