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
2161–2184 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 12, 2007
SMS GLUCOSE CONTROL, MODEL 2120061
K070649 · JJX
Spectrum Medical Supply, Inc.
Chemistry · 35d
Cleared Apr 11, 2007
AMMONIA/ALCOHOL CONTROL SET
K070504 · JJY
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Apr 11, 2007
TECO HOMOCYSTEINE ENZYMATIC ASSAY
K063701 · LPS
Teco Diagnostics
Chemistry · 119d
Cleared Apr 10, 2007
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
K070850 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 13d
Cleared Apr 09, 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL,...
K070734 · LCP
Diazyme Laboratories
Chemistry · 24d
Cleared Apr 09, 2007
ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
K070641 · NBW
Taidoc Technology Corporation
Chemistry · 32d
Cleared Apr 09, 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS,...
K063720 · DHA
Ortho-Clinical Diagnostics
Chemistry · 115d
Cleared Apr 06, 2007
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
K062862 · KNK
Olympus America, Inc.
Chemistry · 193d
Cleared Apr 06, 2007
COMBI SCAN100
K061846 · JIL
Analyticon Biotechnologies AG
Chemistry · 284d
Cleared Apr 06, 2007
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
K061812 · JIL
Analyticon Biotechnologies AG
Chemistry · 284d
Cleared Apr 02, 2007
LYPHOCHEK DIABETES CONTROL
K070546 · GGM
Bio-Rad Laboratories
Chemistry · 35d
Cleared Mar 30, 2007
CISBIO RENIN RIA TEST
K062120 · CIB
Cis Bio International
Chemistry · 248d
Cleared Mar 28, 2007
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
K061377 · MSJ
Pointe Scientific, Inc.,
Chemistry · 315d
Cleared Mar 23, 2007
OLYMPUS TRIGLYCERIDE TEST SYSTEM
K063804 · CDT
Olympus America, Inc.
Chemistry · 91d
Cleared Mar 23, 2007
THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
K061412 · JFY
Thermo-Electron Corp.
Chemistry · 305d
Cleared Mar 21, 2007
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND...
K063663 · DDG
Dade Behring, Inc.
Chemistry · 103d
Cleared Mar 21, 2007
HBA1C
K063209 · LCP
Thermo Electron OY
Chemistry · 149d
Cleared Mar 20, 2007
ELECSYS PTH TEST SYSTEM
K070391 · CEW
Roche Diagnostics Corp.
Chemistry · 39d
Cleared Mar 19, 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · JJY
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Mar 19, 2007
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
K063756 · MMI
Dade Behring, Inc.
Chemistry · 90d
Cleared Mar 16, 2007
OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
K062521 · JIT
Thermo-Electron Corp.
Chemistry · 200d
Cleared Mar 15, 2007
CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD...
K070472 · NBW
Taidoc Technology Corporation
Chemistry · 23d
Cleared Mar 13, 2007
AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
K070223 · JJY
Aalto Scientific, Ltd.
Chemistry · 48d
Cleared Mar 13, 2007
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
K060452 · JLX
Neo-Genesis
Chemistry · 385d