FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
3313–3336 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 13, 2001
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT....
K013102 · JMO
Wiener Laboratories Saic
Chemistry · 57d
Cleared Nov 13, 2001
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
K013097 · JIY
Wiener Laboratories Saic
Chemistry · 57d
Cleared Nov 09, 2001
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372 · LCX
Unipath , Ltd.
Chemistry · 29d
Cleared Nov 09, 2001
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
K013152 · LBS
Elan Holdings, Inc.
Chemistry · 50d
Cleared Nov 09, 2001
N LP(A) STANDARD SY
K013126 · JIS
Dade Behring, Inc.
Chemistry · 51d
Cleared Nov 08, 2001
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
K012326 · JGJ
Wiener Laboratories Saic
Chemistry · 108d
Cleared Nov 07, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
K012987 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 62d
Cleared Nov 02, 2001
OMNI C ANALYZER
K013373 · CEM
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Nov 02, 2001
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
K012829 · KQO
Biocare Corp.
Chemistry · 71d
Cleared Nov 02, 2001
GLYCOSAL II HBA 1C TEST
K011933 · LCP
Provalis Diagnostics , Ltd.
Chemistry · 135d
Cleared Oct 25, 2001
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · KLS
Bayer Corp.
Chemistry · 24d
Cleared Oct 24, 2001
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
K013147 · JJX
Bionostics, Inc.
Chemistry · 34d
Cleared Oct 22, 2001
BIOSCANNER PLUS
K013173 · CHH
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Oct 18, 2001
N LP(A) CONTROL SY
K013130 · JJX
Dade Behring, Inc.
Chemistry · 29d
Cleared Oct 16, 2001
MODIFICATION TO SYNCHRON CONTROL
K013235 · JJY
Beckman Coulter, Inc.
Chemistry · 18d
Cleared Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
K012900 · JIT
Beckman Coulter, Inc.
Chemistry · 48d
Cleared Oct 16, 2001
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
K012878 · JIS
Thermo Dma, Inc.
Chemistry · 49d
Cleared Oct 16, 2001
POLY STAT HCG TEST
K012559 · JHI
Bion Diagnostic Sciences
Chemistry · 69d
Cleared Oct 15, 2001
MODIFICATION TO ALPHA DX SYSTEM
K013118 · JHX
First Medical, Inc.
Chemistry · 27d
Cleared Oct 15, 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · CFR
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 15, 2001
RAICHEM BUN RATE REAGENT
K012649 · CDQ
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 10, 2001
UNIMARK HCG COMBO PREGNANCY TEST
K013194 · JHI
Biotech Atlantic, Inc.
Chemistry · 15d
Cleared Oct 10, 2001
WIENER LAB. CREATININA CINETICA AA
K012065 · JFY
Wiener Laboratories Saic
Chemistry · 100d
Cleared Oct 09, 2001
TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
K012518 · CJE
Thermo Dma, Inc.
Chemistry · 64d