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
9529–9552 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 04, 1985
FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES
K844346 · JHJ
Fisher Diagnostics
Chemistry · 115d
Cleared Mar 04, 1985
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
K850159 · JHI
Hybritech, Inc.
Chemistry · 48d
Cleared Mar 04, 1985
LEECO CONCEP-7-BHCG LEIAD II
K850201 · JHI
Leeco Diagnostics, Inc.
Chemistry · 45d
Cleared Mar 04, 1985
TERUMO SENSIBEAD EIA TSH KIT
K850376 · JLW
Terumo Medical Corp.
Chemistry · 32d
Cleared Mar 01, 1985
OSMOLARITY STANDARDS
K844589 · JMZ
Rna Medical Corp.
Chemistry · 95d
Cleared Mar 01, 1985
IMA-TROL IMMUNOASSAY CONTROL
K844848 · JJY
Dimension Diagnostics
Chemistry · 78d
Cleared Mar 01, 1985
ABBOTT RF EIA DIAGNOSTIC KIT
K850373 · DHR
Abbott Laboratories
Chemistry · 29d
Cleared Mar 01, 1985
LDH REAGENT FOR DEMAND ANALYZER
K850378 · CFJ
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
DIRECT BILIRUBIN FOR DEMAND ANALYZER
K850379 · CIG
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER
K850380 · CEO
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
MAGNESIUM REAGENT FOR DEMAND ANALYZER
K850381 · JGJ
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
PRL QUIK RIA KIT
K850383 · CFT
Pacific Biotech, Inc.
Chemistry · 28d
Cleared Feb 27, 1985
ULTROSER G
K844413 · JJY
Lkb Instruments, Inc.
Chemistry · 105d
Cleared Feb 27, 1985
COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS
K844423 · CDZ
Diagnostic Products Corp.
Chemistry · 104d
Cleared Feb 27, 1985
QUICK-LYTE
K850209 · JGS
Seragen Diagnostics, Inc.
Chemistry · 40d
Cleared Feb 27, 1985
GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER
K850260 · JQT
Gelman Sciences, Inc.
Chemistry · 36d
Cleared Feb 27, 1985
ROCHE STANDARDS FOR CHLORIDE & CO2
K850396 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Feb 12, 1985
GLUCOCHEK III
K842474 · JJQ
Larken Industries, Inc.
Chemistry · 232d
Cleared Feb 12, 1985
ENZYGNOST LIPASE TEST
K844240 · CET
Behring Diagnostics, Inc.
Chemistry · 103d
Cleared Feb 12, 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · JHJ
Abbott Laboratories
Chemistry · 56d
Cleared Feb 12, 1985
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT
K850319 · JQB
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Feb 07, 1985
EPICHROME PAP
K844968 · JFH
Cetus Corp.
Chemistry · 45d
Cleared Feb 07, 1985
ISOCONTROL SERUM LD-
K850211 · JJT
Sclavo, Inc.
Chemistry · 23d
Cleared Feb 07, 1985
ISOENZYME TEST CK-MB
K850212 · CGS
Sclavo, Inc.
Chemistry · 23d