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
2305–2328 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · LDP
Dade Behring, Inc.
Chemistry · 27d
Cleared Jul 10, 2006
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788 · DIF
Biosite Incorporated
Chemistry · 109d
Cleared Jul 06, 2006
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
K061181 · NBW
Taidoc Technology Corporation
Chemistry · 70d
Cleared Jul 06, 2006
PRODIGY
K053593 · NBW
Diagnostic Devices, Inc.
Chemistry · 195d
Cleared Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
K061390 · JIX
Dade Behring, Inc.
Chemistry · 48d
Cleared Jul 03, 2006
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · LCX
Unipath , Ltd.
Chemistry · 10d
Cleared Jul 03, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND...
K060480 · CGR
Ortho-Clinical Diagnostics
Chemistry · 130d
Cleared Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
K061218 · JIX
Dade Behring, Inc.
Chemistry · 60d
Cleared Jun 23, 2006
CREATININE
K061193 · CGX
Abbott Laboratories, Inc.
Chemistry · 56d
Cleared Jun 19, 2006
MULTI-USE ELECTRONIC PREGNANCY TEST
K060825 · LCX
Mizuho USA, Inc.
Chemistry · 84d
Cleared Jun 19, 2006
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
K060510 · JJX
Drew Scientific , Ltd.
Chemistry · 112d
Cleared Jun 16, 2006
EZ SMART-168 GLUCOSE MONITORING SYSTEM
K052818 · NBW
Tyson Bioresearch, Inc.
Chemistry · 255d
Cleared Jun 15, 2006
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
K061464 · JMO
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Jun 15, 2006
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION...
K060364 · JKA
Teco Diagnostics
Chemistry · 122d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · MMI
Abbott Laboratories
Chemistry · 76d
Cleared Jun 13, 2006
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
K061328 · NBW
E-San Limited
Chemistry · 32d
Cleared Jun 13, 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE...
K061296 · LPS
Diazyme Laboratories
Chemistry · 35d
Cleared Jun 13, 2006
ICHEM 100 URINE CHEMISTRY ANALYZER
K060280 · JIL
Iris International, Inc.
Chemistry · 131d
Cleared Jun 06, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE...
K060632 · NBC
Ortho-Clinical Diagnostics, Inc.
Chemistry · 89d
Cleared Jun 06, 2006
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST
K053033 · DJC
Acro Biotech, LLC
Chemistry · 222d
Cleared Jun 05, 2006
GLUCOPACK
K052469 · NBW
Healthpia America Corp.
Chemistry · 270d
Cleared Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
K061282 · JIT
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 02, 2006
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM,...
K061073 · DXN
Taidoc Technology Corporation
Chemistry · 46d
Cleared May 31, 2006
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
K061251 · JIS
Dade Behring, Inc.
Chemistry · 27d