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
2329–2352 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 30, 2006
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
K061196 · JJY
Microgenics Corp.
Chemistry · 32d
Cleared May 30, 2006
NOD CHEMISTRY CONTROL
K060850 · JJY
Bioresource Technology, Inc.
Chemistry · 63d
Cleared May 25, 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX...
K061238 · KHS
Dade Behring, Inc.
Chemistry · 22d
Cleared May 25, 2006
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2
K061182 · JJY
Cliniqa Corporation
Chemistry · 28d
Cleared May 25, 2006
ARCHITECT BNP ASSAY, MODEL 8K28
K060964 · NBC
Fujirebio Diagnostics,Inc.
Chemistry · 48d
Cleared May 25, 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · LCX
Unipath , Ltd.
Chemistry · 127d
Cleared May 25, 2006
PURE-AID PREGNANCY TEST
K053452 · LCX
Bio Focus Co., Lt.
Chemistry · 164d
Cleared May 19, 2006
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
K061118 · NBW
Lifescan, Inc.
Chemistry · 28d
Cleared May 19, 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · DKZ
Dade Behring, Inc.
Chemistry · 169d
Cleared May 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
K061048 · CFR
Roche Diagnostics Corp.
Chemistry · 30d
Cleared May 15, 2006
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K060321 · DQD
American Diagnostic Corp.
Chemistry · 95d
Cleared May 10, 2006
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE,...
K061020 · CKA
Dade Behring, Inc.
Chemistry · 27d
Cleared May 05, 2006
GLUCOSE
K060383 · CFR
Abbott Laboratories
Chemistry · 80d
Cleared May 04, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
K060369 · NQD
Dade Behring, Inc.
Chemistry · 80d
Cleared May 04, 2006
CARBON DIOXIDE
K060295 · KHS
Abbott Laboratories
Chemistry · 87d
Cleared May 03, 2006
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
K060585 · CKG
Roche Diagnostics Corp.
Chemistry · 57d
Cleared May 03, 2006
TOTAL BILIRUBIN
K060574 · CIG
Abbott Laboratories
Chemistry · 58d
Cleared Apr 28, 2006
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
K060935 · CGX
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Apr 28, 2006
IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE...
K060929 · CDD
Diagnostic Products Corporation
Chemistry · 23d
Cleared Apr 28, 2006
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
K060706 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 43d
Cleared Apr 28, 2006
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
K060345 · CGA
Nova Biomedical Corp.
Chemistry · 77d
Cleared Apr 28, 2006
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
K060139 · DCK
Diagnostic Chemicals , Ltd.
Chemistry · 99d
Cleared Apr 26, 2006
DRI-STAT ACID PHOSPHATASE REAGENT
K053612 · CKB
Beckman Coulter, Inc.
Chemistry · 120d
Cleared Apr 24, 2006
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
K060140 · JIT
Diagnostic Chemicals , Ltd.
Chemistry · 95d