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
1801–1824 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 08, 2009
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K083716 · LCX
Church & Dwight Co., Inc.
Chemistry · 175d
Cleared Jun 05, 2009
CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
K090283 · JIX
Genchem, Inc.
Chemistry · 120d
Cleared Jun 04, 2009
EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
K090629 · NBW
Tyson Bioresearch, Inc.
Chemistry · 87d
Cleared Jun 03, 2009
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY...
K090737 · JKA
Bio-Rad Laboratories, Inc.
Chemistry · 75d
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 May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT,...
K090413 · LCP
Bayer Healthcare, LLC
Chemistry · 85d
Cleared 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