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
6865–6888 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 09, 1990
ROCHE ISOMUNE- CK
K903025 · JHS
Roche Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Aug 09, 1990
SYNERMED CHLORIDE REAGENT KIT
K903103 · CHG
Synermed, Inc.
Chemistry · 27d
Cleared Aug 09, 1990
CHEM-CHEX-ALT
K903147 · JJX
Streck Laboratories, Inc.
Chemistry · 22d
Cleared Aug 09, 1990
EURAMARK 610 PHOTOMETER
K903164 · JJQ
Euro-American Marketing Group, Inc.
Chemistry · 22d
Cleared Aug 02, 1990
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
K901981 · LCX
Abbott Laboratories
Chemistry · 92d
Cleared Aug 02, 1990
LUMATAG(TM) LH DIAGNOSTIC KIT
K902443 · CEP
London Diagnostics, Inc.
Chemistry · 62d
Cleared Aug 02, 1990
MILENIA (TM) FERRITIN
K902997 · JMG
Diagnostic Products Corp.
Chemistry · 31d
Cleared Aug 01, 1990
ACS 0.02 M CALCIUM CHLORIDE
K902458 · JPA
Analytical Control Systems, Inc.
Chemistry · 58d
Cleared Jul 31, 1990
IONOMETER EF-HK AND ACCESSORIES
K901042 · JGS
Fresenius USA, Inc.
Chemistry · 147d
Cleared Jul 31, 1990
COULTER HDL - CHOLESTEROL REAGENT
K902174 · LBR
Coulter Corp.
Chemistry · 78d
Cleared Jul 31, 1990
DMA TRIGLYCERIDE (GPO) PROCEDURE
K902202 · JGY
Data Medical Associates, Inc.
Chemistry · 76d
Cleared Jul 31, 1990
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
K902326 · JFJ
Catachem, Inc.
Chemistry · 68d
Cleared Jul 31, 1990
MULTI ANALYTE MIXTURE, CALIBRATORS
K902675 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 42d
Cleared Jul 31, 1990
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
K902776 · JJQ
Slt Labinstruments, Inc.
Chemistry · 36d
Cleared Jul 31, 1990
SYNERMED SERUM IRON REAGENT KIT
K902918 · CFM
Synermed, Inc.
Chemistry · 28d
Cleared Jul 31, 1990
SYNERMED MAGNESIUM REAGENT KIT
K902919 · JGJ
Synermed, Inc.
Chemistry · 28d
Cleared Jul 30, 1990
OPUS TM T-UPTAKE TEST SYSTEM
K902797 · KHQ
Pb Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Jul 27, 1990
SECUTAINER
K902709 · JKA
Preserve
Chemistry · 37d
Cleared Jul 27, 1990
AMERSHAM TSH CONTROL SERA
K902760 · JJX
Amersham Corp.
Chemistry · 32d
Cleared Jul 27, 1990
TOTAL IRON FOR MANUAL/AUTOMATED
K902877 · JIY
Catachem, Inc.
Chemistry · 25d
Cleared Jul 27, 1990
MICROZYME T4 ENZYME IMMUNOASSAY KIT
K902922 · CDX
Immunotech Corp.
Chemistry · 24d
Cleared Jul 27, 1990
SYNERMED TRIGLYCERIDES REAGENT KIT
K903016 · CDT
Synermed, Inc.
Chemistry · 17d
Cleared Jul 24, 1990
L.D.X LIPID MONITORING SYSTEM
K901900 · CHH
Cholestech Corp.
Chemistry · 88d
Cleared Jul 19, 1990
IONOMETER EH-F AND ACCESSORIES
K901040 · JGS
Fresenius USA, Inc.
Chemistry · 135d