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
6481–6504 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (CHE)
K913198 · DIH
Eastman Kodak Company
Chemistry · 39d
Cleared Aug 26, 1991
URINE COLLECTION KIT/DEVICE
K913330 · KHP
Medical Implements, Inc.
Chemistry · 32d
Cleared Aug 16, 1991
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
K911217 · KLI
Serono-Baker Diagnostics, Inc.
Chemistry · 150d
Cleared Aug 16, 1991
ENZYMATICS, INC., TOTAL CHOLESTEROL TEST
K911692 · CHH
Enzymatics C/O Burditt,Bowles,Radzius...
Chemistry · 122d
Cleared Aug 16, 1991
HIGH DENSITY LIPOPROTEIN CHOLESTEROL
K912823 · LBR
Creative Laboratory Products, Inc.
Chemistry · 51d
Cleared Aug 16, 1991
DIRECTIGEN 1-2-3(TM) HCG TEST
K913122 · JHI
Quidel Corp.
Chemistry · 32d
Cleared Aug 12, 1991
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL
K912455 · JJY
Baxter Healthcare Corp
Chemistry · 70d
Cleared Aug 12, 1991
MILENIA TOTAL T4, CATALOG: MKT41,5
K912541 · CDX
Diagnostic Products Corp.
Chemistry · 63d
Cleared Aug 12, 1991
MAGIC LITE TSH (HS) IMMUNOASSAY
K912583 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 61d
Cleared Aug 12, 1991
BIOTROL UIBC REAGENT
K912795 · JMO
Biotrol, USA, Inc.
Chemistry · 48d
Cleared Aug 12, 1991
FSH IRMA IMMUNOMAG
K912804 · CGJ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 48d
Cleared Aug 12, 1991
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
K912809 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 12, 1991
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3
K912827 · DKC
Cala Diagnostics
Chemistry · 47d
Cleared Aug 12, 1991
SHBG
K912850 · CDZ
Wien Laboratories, Inc.
Chemistry · 45d
Cleared Aug 12, 1991
REFLOTRON CREATININE TEST TABS
K913105 · JFY
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Aug 12, 1991
ROCHE REAGENT FOR AMMONIA
K913124 · JIF
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 12, 1991
ROCHE REAGENT FOR ETHANOL
K913125 · DIC
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 02, 1991
LUMATAG T4 CHEMILUMINESCENCE ASSAY
K911985 · CDX
London Diagnostics, Inc.
Chemistry · 88d
Cleared Jul 30, 1991
CHOLESTECH LIPID MONITORING SYS.
K912136 · CHH
Cholestech Corp.
Chemistry · 77d
Cleared Jul 30, 1991
REP ALP-15, 8, & 4 KITS
K912603 · CIN
Helena Laboratories
Chemistry · 50d
Cleared Jul 30, 1991
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
K912725 · JJY
Creative Laboratory Products, Inc.
Chemistry · 40d
Cleared Jul 30, 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 30, 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 30, 1991
LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY
K912858 · CFL
London Diagnostics, Inc.
Chemistry · 32d