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
1801–1824 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 06, 2009
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS,...
K090358 · LEG
Abbott Laboratories, Inc.
Chemistry · 175d
Cleared Aug 03, 2009
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
K091333 · MRR
Alfa Wassermann, Inc.
Chemistry · 89d
Cleared Jul 31, 2009
GLUCOMANAGER DATA MANAGEMENT SOFTWARE
K091229 · NBW
Eps Bio Technology Corp.
Chemistry · 95d
Cleared Jul 31, 2009
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
K083222 · LPS
Axis-Shield Diagnostics, Ltd.
Chemistry · 270d
Cleared Jul 27, 2009
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS...
K090699 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 132d
Cleared Jul 23, 2009
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
K090766 · DJZ
Lifeloc Technologies, Inc.
Chemistry · 122d
Cleared Jul 17, 2009
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
K091296 · NBW
Polymap Wireless
Chemistry · 74d
Cleared Jul 17, 2009
EASYRA DLDL REAGENT, CALIBRATOR
K090734 · MRR
Medica Corp.
Chemistry · 120d
Cleared Jul 14, 2009
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
K090389 · NBW
Bestgen Biotech Corp.
Chemistry · 147d
Cleared Jul 13, 2009
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153 · KHS
Beckman Coulter, Inc.
Chemistry · 83d
Cleared Jul 13, 2009
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
K090188 · NBW
Taidoc Technology Corporation
Chemistry · 168d
Cleared Jul 09, 2009
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
K083130 · NQL
Perkinelmer, Inc.
Chemistry · 259d
Cleared Jul 02, 2009
ELECSYS PRECICONTROL UNIVERSAL
K090541 · JJY
Roche Diagnostics
Chemistry · 122d
Cleared Jun 25, 2009
VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
K091225 · JJY
Maine Standards Co.
Chemistry · 59d
Cleared Jun 24, 2009
BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
K090109 · CGA
Epocal, Inc.
Chemistry · 160d
Cleared Jun 23, 2009
FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO...
K090404 · NBW
Taidoc Technology Corporation
Chemistry · 126d
Cleared Jun 19, 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE...
K082340 · CGN
Roche Diagnostics Corp.
Chemistry · 308d
Cleared Jun 18, 2009
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT...
K090939 · DKB
Roche Diagnostics
Chemistry · 76d
Cleared Jun 16, 2009
RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
K081150 · LCX
Turklab Medical Devices, Inc.
Chemistry · 419d
Cleared Jun 11, 2009
MODIFICATION TO AVIE A1C TEST SYSTEM
K091400 · LCP
Mec Dynamics Corp
Chemistry · 30d
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