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
8305–8328 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 22, 1987
TOTAL BILIRUBIN STANDARD CALIBRATOR
K872263 · JIT
Wako Chemicals USA, Inc.
Chemistry · 40d
Cleared Jul 21, 1987
INNOFLUOR PHENYTOIN CALIBRATOR SET
K872142 · DLJ
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Jul 21, 1987
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
K872286 · CDX
Ciba Corning Diagnostics Corp.
Chemistry · 35d
Cleared Jul 21, 1987
INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET
K872349 · DLJ
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Jul 21, 1987
CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS
K872511 · CHJ
Catachem, Inc.
Chemistry · 27d
Cleared Jul 21, 1987
FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH
K872627 · CGJ
Serono Diagnostics, Inc.
Chemistry · 15d
Cleared Jul 20, 1987
TDXR FETAL LUNG MATURITY
K871593 · JHG
Abbott Laboratories
Chemistry · 87d
Cleared Jul 16, 1987
V-MARC 88A COMPUTER
K871853 · JQP
V.Marc, A Div. of Pictorial, Inc.
Chemistry · 65d
Cleared Jul 16, 1987
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
K872130 · JHI
Syva Co.
Chemistry · 44d
Cleared Jul 16, 1987
CHOLESTEROL REAGENT
K872295 · CHH
Sigma Diagnostics, Inc.
Chemistry · 30d
Cleared Jul 16, 1987
DYNATECH SPD 3000, #002-900-0000
K872363 · JQW
Dynatech Laboratories, Inc.
Chemistry · 28d
Cleared Jul 16, 1987
HDL CHOLESTEROL REAGENT
K872575 · CHH
Sigma Chemical Co.
Chemistry · 16d
Cleared Jul 16, 1987
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM
K872582 · LDM
Millipore Corp.
Chemistry · 16d
Cleared Jul 15, 1987
HCG MAB SOLID PHASE COMPONENT SYSTEM
K871700 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 75d
Cleared Jul 09, 1987
AFFINITY(TM) I UPTAKE IMMUNIT(TM)
K865083 · KHQ
Bd Becton Dickinson Vacutainer...
Chemistry · 191d
Cleared Jul 09, 1987
DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
K871977 · JJY
American Dade
Chemistry · 48d
Cleared Jul 09, 1987
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT
K872311 · JGJ
Abbott Laboratories
Chemistry · 22d
Cleared Jul 09, 1987
HITACHI 717 CHEMISTRY ANALYZER
K872494 · JJE
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Jul 07, 1987
UNI-FAST LACTATE DEHYDROGENASE (LDH-L)
K872030 · CFJ
Sclavo, Inc.
Chemistry · 42d
Cleared Jul 07, 1987
PARAMAX CHOLESTEROL REAGENT
K872050 · LBS
American Dade
Chemistry · 40d
Cleared Jul 07, 1987
CORNING EASY WASH ELISA PLATES
K872273 · LIB
Corning Medical & Scientific
Chemistry · 22d
Cleared Jul 07, 1987
UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE)
K872303 · JJY
Vanguard Diagnostic Systems
Chemistry · 22d
Cleared Jul 07, 1987
UNASSAYED CONTROL SERUM, NORMAL (BOVINE)
K872304 · JJY
Vanguard Diagnostic Systems
Chemistry · 22d
Cleared Jul 07, 1987
DIGOXIN FPIA CALIBRATORS
K872328 · DLJ
Sigma Chemical Co.
Chemistry · 20d