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
1825–1848 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 27, 2009
ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
K090943 · JJX
American Biological Technologies, Inc.
Chemistry · 54d
Cleared May 27, 2009
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE,...
K090588 · CDD
Beckman Coulter, Inc.
Chemistry · 84d
Cleared May 22, 2009
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC...
K090330 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 101d
Cleared CT May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT,...
K090413 · LCP
Bayer Healthcare, LLC
Chemistry · 85d
Cleared CT May 14, 2009
TEARLAB OSMOLARITY SYSTEM
K083184 · OND
Ocusense, Inc.
Chemistry · 198d
Cleared May 12, 2009
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K090187 · NBW
Taidoc Technology Corporation
Chemistry · 106d
Cleared May 08, 2009
ADVIA CENTAUR TSH3-ULTRA METHOD
K083844 · JLW
Siemens Healthcare Diagnostics
Chemistry · 135d
Cleared May 01, 2009
GLUCODR AUTO SYSTEM
K083628 · NBW
All Medicus Co., Ltd.
Chemistry · 144d
Cleared Apr 24, 2009
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM
K090185 · NBW
Taidoc Technology Corporation
Chemistry · 88d
Cleared Apr 21, 2009
CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
K083554 · JJY
Cliniqa Corporation
Chemistry · 141d
Cleared Apr 21, 2009
ONE STEP HCG URINE/SERUM TEST
K072500 · DHA
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 594d
Cleared Apr 16, 2009
ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
K090854 · JJX
American Biological Technologies, Inc.
Chemistry · 17d
Cleared Apr 16, 2009
VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
K090475 · JJY
Maine Standards Co.
Chemistry · 51d
Cleared Apr 16, 2009
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20...
K083223 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 164d
Cleared Apr 16, 2009
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K081922 · JLX
Wallac OY
Chemistry · 283d
Cleared Apr 09, 2009
AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
K090043 · CGA
Apex BioTechnology Corp.
Chemistry · 92d
Cleared Apr 08, 2009
ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
K090057 · NBW
Acon Laboratories Co.
Chemistry · 90d
Cleared Apr 08, 2009
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
K082251 · DCF
Beckman Coulter, Inc.
Chemistry · 243d
Cleared Apr 07, 2009
CREATININE
K083809 · CGX
Abbott Laboratories
Chemistry · 106d
Cleared Apr 02, 2009
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL),...
K083386 · CJY
Siemens Healthcare Diagnostics
Chemistry · 136d
Cleared Mar 27, 2009
TRUEBALANCE BLOOD GLUCOSE SYSTEM
K090495 · NBW
Home Diagnostics, Inc.
Chemistry · 30d
Cleared Mar 26, 2009
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
K090536 · NBW
Taidoc Technology Corporation
Chemistry · 27d
Cleared Mar 24, 2009
BETACHEK GLUCOSE TEST
K062187 · NBW
National Diagnostic Products
Chemistry · 966d
Cleared Mar 23, 2009
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
K083891 · JJY
Maine Standards Co.
Chemistry · 84d