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
8785–8808 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 26, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG)
K861386 · JGJ
Eastman Kodak Company
Chemistry · 134d
Cleared Aug 26, 1986
ELECTROPHORESIS WORK CENTER (EWC)
K861414 · JJN
Helena Laboratories
Chemistry · 133d
Cleared Aug 26, 1986
BUN (RATE) REAGENT
K863196 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 7d
Cleared Aug 19, 1986
ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
K860823 · CFT
Cis-Us, Inc.
Chemistry · 168d
Cleared Aug 19, 1986
WAKO MICRO TP
K861508 · CEK
Wako Chemicals USA, Inc.
Chemistry · 118d
Cleared Aug 19, 1986
ENZYMUN-TEST HCG
K862108 · DHA
Boehringer Mannheim Corp.
Chemistry · 77d
Cleared Aug 19, 1986
KING DIAGNOSTICS LDH TEST
K862306 · CFJ
King Diagnostics, Inc.
Chemistry · 63d
Cleared Aug 19, 1986
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
K862359 · CIG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Aug 19, 1986
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
K862428 · JLW
American Dade
Chemistry · 54d
Cleared Aug 19, 1986
SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
K862439 · CGJ
Boots-Celltech Diagnostics, Inc.
Chemistry · 54d
Cleared Aug 19, 1986
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
K862453 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 53d
Cleared Aug 19, 1986
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
K862525 · JIT
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 19, 1986
SERACON(TM) CAL (PRODUCT NO. DO35)
K862594 · JIX
Bhp Diagnostix, Inc.
Chemistry · 42d
Cleared Aug 19, 1986
DOUBLE ANTIBODY ESTRADIOL RIA KIT
K862603 · CHP
Diagnostic Products Corp.
Chemistry · 42d
Cleared Aug 19, 1986
SURESPOT
K862701 · JQW
Helena Laboratories
Chemistry · 35d
Cleared Aug 19, 1986
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
K862704 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Aug 19, 1986
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
K862706 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Aug 19, 1986
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
K862707 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Aug 19, 1986
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K862818 · JJE
American Dade
Chemistry · 26d
Cleared Aug 19, 1986
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT
K862833 · CKA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 25d
Cleared Aug 19, 1986
MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT
K862834 · CEO
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 25d
Cleared Aug 19, 1986
RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
K862871 · CGR
Cambridge Medical Technology
Chemistry · 21d
Cleared Aug 19, 1986
ICON READER
K862956 · JQT
Hybritech, Inc.
Chemistry · 14d
Cleared Aug 19, 1986
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95
K863002 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 11d