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
3217–3240 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 24, 2002
SPECTRAL'S 2 IN 1 (TNI-MYO)
K020950 · MMI
Spectral Diagnostics, Inc.
Chemistry · 60d
Cleared May 23, 2002
STATUS HCG SERUM/URINE
K020439 · JHI
Princeton BioMeditech Corp.
Chemistry · 101d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-COMBO
K020801 · JHI
Quidel Corp.
Chemistry · 66d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-URINE
K020799 · JHI
Quidel Corp.
Chemistry · 66d
Cleared May 14, 2002
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
K020816 · JIY
Diagnostic Chemicals , Ltd.
Chemistry · 62d
Cleared May 14, 2002
NYCOCARD CRP
K013787 · DCK
Primus Corp.
Chemistry · 181d
Cleared May 10, 2002
OCTEIA 25-HYDROXY VITAMIN D
K021163 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 29d
Cleared May 09, 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
K020724 · MRR
Dade Behring, Inc.
Chemistry · 64d
Cleared May 08, 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
K020723 · JIT
Dade Behring, Inc.
Chemistry · 63d
Cleared May 06, 2002
SPIFE 2000/3000 ALP 40, 20
K020625 · CIN
Helena Laboratories
Chemistry · 69d
Cleared Apr 30, 2002
GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
K020210 · NBW
Bayer Group Diagnostics
Chemistry · 98d
Cleared Apr 29, 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
K021155 · JJW
Medical Analysis Systems, Inc.
Chemistry · 19d
Cleared Apr 29, 2002
CALIBRATING MATERIAL, CAL-PAK, BUFFERS
K020894 · JIT
Mission Diagnostics
Chemistry · 41d
Cleared Apr 29, 2002
GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
K020208 · NBW
Bayer Group Diagnostics
Chemistry · 97d
Cleared Apr 22, 2002
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
K020610 · DIE
Bio-Rad
Chemistry · 56d
Cleared Apr 15, 2002
CARESIDE TRGLYCERIDE
K020488 · CDT
Careside, Inc.
Chemistry · 61d
Cleared Apr 12, 2002
LIQUICHEK URINE CHEMISTRY CONTROL
K020817 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 30d
Cleared Apr 12, 2002
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/...
K020662 · MMI
Ortho-Clinical Diagnostics
Chemistry · 42d
Cleared Apr 12, 2002
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
K020575 · MRR
Elan Diagnostics
Chemistry · 50d
Cleared Apr 08, 2002
CHEMISTRY CALIBRATOR
K020454 · JIT
Jas Diagnostics, Inc.
Chemistry · 56d
Cleared Apr 05, 2002
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
K020548 · CEC
Monobind
Chemistry · 45d
Cleared Apr 03, 2002
HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
K020935 · CGA
Hemocue, Inc.
Chemistry · 12d
Cleared Apr 03, 2002
SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
K012221 · JKA
Biosafe Laboratories, Inc.
Chemistry · 261d
Cleared Mar 29, 2002
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
K020467 · CFE
Helena Laboratories
Chemistry · 45d