FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

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

Filters: Chemistry ×
13,224 results
10657–10680 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 28, 1983
TOTAL IRON BINDING CAPACITY TEST
K830032 · JQF
Sclavo, Inc.
Chemistry · 21d
Cleared Jan 28, 1983
SOPHEIA DIGITOXIN EIA KIT & COMPONENTS
K830035 · LFM
Diagnostic Products Corp.
Chemistry · 21d
Cleared Jan 28, 1983
NEONATAL NTSH RADIOIMMUNOASSAY SYS
K830036 · JLW
Corning Medical & Scientific
Chemistry · 21d
Cleared Jan 28, 1983
ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL
K830049 · LAS
Syva Co.
Chemistry · 18d
Cleared Jan 28, 1983
PHADEBAS & PHADEZYME RAST ALLERGEN DISC
K830096 · DHB
Pharmacia, Inc.
Chemistry · 17d
Cleared Jan 28, 1983
COLORIMETERS SERIES ONE 12
K830101 · JJQ
Innotron of Oregon, Inc.
Chemistry · 17d
Cleared Jan 28, 1983
SERUM IRON DIAGNOSTIC TEST KITS
K830104 · CEM
Sclavo, Inc.
Chemistry · 17d
Cleared Jan 26, 1983
MICRO Z BLOOD COLLECTING NEEDLES
K823696 · FMI
Hospital Products Co.
Chemistry · 49d
Cleared Jan 24, 1983
GENESIS B-HCG
K823753 · JHI
Armkel, LLC
Chemistry · 41d
Cleared Jan 24, 1983
URIC ACID TEST
K823846 · KNK
Scalavo, Inc.
Chemistry · 34d
Cleared Jan 14, 1983
CLEANING AGENT
K823750 · CHL
Shaban Mfg. Co.
Chemistry · 31d
Cleared Jan 14, 1983
ENZYMATIC CHOLESTEROL (COLORIMETRIC
K823784 · CHH
Analytical & Research Chemicals, Inc.
Chemistry · 29d
Cleared Jan 14, 1983
ALKALINE PHOSPHATASE
K823786 · CJE
Analytical & Research Chemicals, Inc.
Chemistry · 29d
Cleared Jan 14, 1983
AMES TDA ETHOSUXIMIDE TEST
K823801 · DLF
Miles Laboratories, Inc.
Chemistry · 28d
Cleared Jan 14, 1983
DIRECT CREATININE PROCEDURE
K823806 · CGX
Analytical & Research Chemicals, Inc.
Chemistry · 29d
Cleared Jan 14, 1983
ADVANCE SYS. EMIT-CAD LIDOCAINE CONTROL
K823865 · LAX
Syva Co.
Chemistry · 22d
Cleared Jan 12, 1983
DOSIMETRIC RELEASE PROGRAM - ADMIN. SET
K823214 · FPA
Cutter Laboratories, Inc.
Chemistry · 76d
Cleared Jan 12, 1983
THYROXINE ANALYSIS PRODUCTS/RADIO-FREE
K823264 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 71d
Cleared Jan 12, 1983
ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG
K823746 · DIF
Syva Co.
Chemistry · 30d
Cleared Jan 12, 1983
SOPHEIA THYROXINE EIA KIT
K823751 · KLI
Diagnostic Products Corp.
Chemistry · 29d
Cleared Jan 12, 1983
ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082
K823756 · CIC
Em Industries, Inc.
Chemistry · 29d
Cleared Jan 12, 1983
VARIOUS-ANALYZER CUPS
K823762 · JJE
Cordis Corp.
Chemistry · 29d
Cleared Jan 12, 1983
ADVANCE EMIT CAD LIDOCAINE ASSAY
K823866 · KLR
Syva Co.
Chemistry · 20d
Cleared Jan 09, 1983
BUN-UN CENTRIFICHUM 500, #65080/81
K823300 · CDQ
Emd Chemicals, Inc.
Chemistry · 65d