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
11545–11568 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 03, 1981
QUANTIMUNE FERRITIN IRMA
K810799 · JMG
Bio-Rad
Chemistry · 11d
Cleared Apr 01, 1981
A-GENT UREA NITROGEN
K810794 · CDQ
Abbott Laboratories
Chemistry · 9d
Cleared Apr 01, 1981
PROGESTERONE KIT
K810804 · JLS
Cambridge Nuclear Corp.
Chemistry · 8d
Cleared Mar 31, 1981
SERALYZER SYSTEM
K810639 · CGA
Miles Laboratories, Inc.
Chemistry · 21d
Cleared Mar 31, 1981
LEECO LH-QUANT DIAGNOSTIC KIT
K810662 · CEP
Leeco Diagnostics, Inc.
Chemistry · 20d
Cleared Mar 31, 1981
AMERLEX ESTRIOL RIA KIT
K810667 · CGI
Amersham Corp.
Chemistry · 19d
Cleared Mar 31, 1981
PANTRAK E.K.
K810669 · CIW
Calbiochem-Behring Corp.
Chemistry · 19d
Cleared Mar 31, 1981
ENZYMATIC CHOLESTEROL
K810673 · CHH
Pointe Scientific, Inc.,
Chemistry · 19d
Cleared Mar 31, 1981
ENZYMATIC TRIGLYCERIDE
K810680 · CDT
Pointe Scientific, Inc.,
Chemistry · 18d
Cleared Mar 31, 1981
ESTRIOL RADIOIMMUNOASSAY TEST KIT
K810695 · CHP
Serono Laboratories, Inc.
Chemistry · 15d
Cleared Mar 31, 1981
COAT-A-COUNT T3 UPTAKE KIT
K810717 · KHQ
Diagnostic Products Corp.
Chemistry · 14d
Cleared Mar 31, 1981
C-PEPTICE REAGENTS
K810718 · JKD
Calbiochem-Behring Corp.
Chemistry · 14d
Cleared Mar 31, 1981
CORNING 178 BLOOD GAS ANALYZER
K810724 · CHL
Corning Medical & Scientific
Chemistry · 14d
Cleared Mar 31, 1981
AST-UV (PLP-ACTIVATED) DETERMINATION
K810727 · CIT
The Dow Chemical Co.
Chemistry · 14d
Cleared Mar 31, 1981
LUMINESCENCE PHOTOMETER 100 SERIES
K810736 · JJQ
Sai Technology
Chemistry · 13d
Cleared Mar 31, 1981
LUTEINIZING HORMONE
K810741 · CEP
Pcl-Ria, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
AQUEOUS TRIOLEIN STANDARDS & KITS
K810742 · JIS
Supelco, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
LECITHIN-SPINGOMYELIN STAND. & KITS
K810743 · JIS
Supelco, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
LUTENIZING HORMONES
K810754 · CEP
Pcl-Ria, Inc.
Chemistry · 11d
Cleared Mar 27, 1981
17B ESTRADIOL
K810204 · CHP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 60d
Cleared Mar 27, 1981
710 FLUOROMETER/DENSITOMETER
K810619 · JQT
Corning Medical & Scientific
Chemistry · 18d
Cleared Mar 27, 1981
HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-
K810625 · DHI
Serono Laboratories, Inc.
Chemistry · 18d
Cleared Mar 27, 1981
DPM CALCULATOR
K810631 · JQP
Iso-Data, Inc.
Chemistry · 17d
Cleared Mar 27, 1981
LEECO FSH-QUANT DIAGNOSTIC KIT
K810663 · CGJ
Leeco Diagnostics, Inc.
Chemistry · 16d