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
3793–3816 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 02, 1999
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
K991867 · CEO
A.P. Total Care, Inc.
Chemistry · 62d
Cleared Aug 02, 1999
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
K991866 · CIG
A.P. Total Care, Inc.
Chemistry · 62d
Cleared Aug 02, 1999
DUET II GLUCOSE CONTROL MONITORING SYSTEM
K990942 · CGA
Lxn Corp.
Chemistry · 133d
Cleared Jul 30, 1999
ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
K991870 · CGZ
A.P. Total Care, Inc.
Chemistry · 59d
Cleared Jul 26, 1999
GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE
K992244 · JKA
Greiner Meditech, Inc.
Chemistry · 24d
Cleared Jul 23, 1999
DOCUMENT THYROID CAL*VER
K992034 · JJY
Casco-Nerl Diagnostics Corporation...
Chemistry · 37d
Cleared Jul 22, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991817 · CIJ
Bayer Corp.
Chemistry · 56d
Cleared Jul 22, 1999
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
K991741 · JHI
Biocheck, Inc.
Chemistry · 62d
Cleared Jul 16, 1999
STAT PROFILE M7 ANALYZER
K991727 · CGL
Nova Biomedical Corp.
Chemistry · 57d
Cleared Jul 15, 1999
N PROTEIN STANDARD UY
K991705 · JIT
Dade Behring, Inc.
Chemistry · 57d
Cleared Jul 13, 1999
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
K991733 · MRR
Schiapparelli Biosystems, Inc.
Chemistry · 53d
Cleared Jul 12, 1999
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
K991917 · JJW
Metrika, Inc.
Chemistry · 35d
Cleared Jul 09, 1999
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K991789 · LBR
Elan Holdings, Inc.
Chemistry · 45d
Cleared Jul 09, 1999
SERUM CROSSLAPS ONE STEP ELISA
K990843 · JMM
Osteometer Biotech A/S
Chemistry · 116d
Cleared Jul 09, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST...
K990649 · CGA
Bayer Corp.
Chemistry · 130d
Cleared Jul 09, 1999
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE...
K983504 · CGA
Medisense, Inc.
Chemistry · 276d
Cleared Jul 06, 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · CEW
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jul 01, 1999
OPUS TROPONIN I (CTN) TEST MODULES
K991177 · MMI
Dade Behring, Inc.
Chemistry · 85d
Cleared Jul 01, 1999
OPUS TROPONIN I CALIBRATOR
K991176 · JIT
Dade Behring, Inc.
Chemistry · 85d
Cleared Jun 30, 1999
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
K991666 · JMO
A.P. Total Care, Inc.
Chemistry · 47d
Cleared Jun 30, 1999
AST/SGOT
K991663 · CIT
A.P. Total Care, Inc.
Chemistry · 47d
Cleared Jun 30, 1999
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K991576 · CIX
Bayer Corp.
Chemistry · 55d
Cleared Jun 30, 1999
GLUCOMETER ELITE TEST STRIPS
K991242 · CGA
Bayer Corp.
Chemistry · 79d
Cleared Jun 25, 1999
GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
K991843 · JKA
Greiner Meditech, Inc.
Chemistry · 28d