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
3193–3216 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 01, 2002
CARESIDE GGT
K020486 · JPZ
Careside, Inc.
Chemistry · 138d
Cleared Jun 28, 2002
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
K021943 · CGA
Lifescan, Inc.
Chemistry · 31d
Cleared Jun 28, 2002
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K021229 · DDR
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Jun 27, 2002
RDI HS CRP KIT
K021609 · DCK
Reference Diagnostics, Inc.
Chemistry · 42d
Cleared Jun 27, 2002
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
K021535 · JIT
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 27, 2002
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
K021532 · JIT
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 25, 2002
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
K021930 · JJY
Bionostics, Inc.
Chemistry · 13d
Cleared Jun 24, 2002
CHOLESTEROL 1, 2, 3
K014018 · LBS
Imi
Chemistry · 200d
Cleared Jun 21, 2002
QUPID PLUS E.R.
K020378 · JHI
Stanbio Laboratory
Chemistry · 136d
Cleared Jun 13, 2002
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
K020603 · DCN
Good Biotech Corp.
Chemistry · 108d
Cleared Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · NBW
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Jun 11, 2002
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
K020866 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 85d
Cleared Jun 10, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297 · CHL
Nova Biomedical Corp.
Chemistry · 133d
Cleared Jun 04, 2002
CARESIDE ALT
K020487 · CKA
Careside, Inc.
Chemistry · 111d
Cleared Jun 04, 2002
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
K020364 · JGS
Phoenix Diagnostics, Inc.
Chemistry · 120d
Cleared Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · NBW
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Jun 03, 2002
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032 · CKG
Scantibodies Laboratory, Inc.
Chemistry · 66d
Cleared May 31, 2002
AXSYM INTACT PTH, MODEL 2G06
K020945 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 67d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS...
K021415 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS...
K021414 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
K021411 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
K021384 · DIF
Bio-Rad
Chemistry · 27d
Cleared May 24, 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
K021498 · JJT
Bio-Rad
Chemistry · 15d
Cleared May 24, 2002
AT HOME OVULATION TEST, MODEL 9032
K021409 · CEP
Phamatech, Inc.
Chemistry · 21d