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
6769–6792 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 12, 1990
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)
K904293 · JJY
Hichem Diagnostics
Chemistry · 23d
Cleared Oct 12, 1990
SECONDARY CALIBRATORS
K904335 · JGS
Bionostics, Inc.
Chemistry · 22d
Cleared Oct 12, 1990
DIAZO COLORIMENTRY DIRECT BILIRUBIN
K904381 · CIG
Amresco, Inc.
Chemistry · 16d
Cleared Oct 12, 1990
LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION
K904458 · CFT
London Diagnostics, Inc.
Chemistry · 11d
Cleared Oct 04, 1990
SUDORMED SWEAT PATCH SPECIMEN CONTAINER
K902442 · JKA
Sudormed, Inc.
Chemistry · 125d
Cleared Oct 04, 1990
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
K902575 · JIW
Diagnostic Products Corp.
Chemistry · 115d
Cleared Oct 04, 1990
SYNERMED CALCIUM REAGENT KIT
K903233 · CIC
Synermed, Inc.
Chemistry · 73d
Cleared Oct 04, 1990
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
K903409 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 65d
Cleared Oct 04, 1990
CREATINE PHOSPHOKINASE
K903775 · CGS
Amresco, Inc.
Chemistry · 45d
Cleared Oct 04, 1990
GEN-PROBE PAL LUMINOMETER
K903911 · JJQ
Gen-Probe, Inc.
Chemistry · 41d
Cleared Oct 04, 1990
DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2
K903933 · JJY
Baxter Healthcare Corp
Chemistry · 38d
Cleared Oct 03, 1990
PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
K903914 · JGQ
Baxter Healthcare Corp
Chemistry · 40d
Cleared Oct 03, 1990
CIBA CORNING ACS HCG IMMUNOASSAY
K904123 · JHI
Ciba Corning Diagnostics Corp.
Chemistry · 27d
Cleared Oct 02, 1990
IMMUNODOT THYROID AUTOIMMUNITY PANEL
K903843 · JNL
General Biometrics, Inc.
Chemistry · 42d
Cleared Oct 01, 1990
N-A-G TEST KIT
K893582 · CGX
Ppr Diagnostics , Ltd.
Chemistry · 510d
Cleared Oct 01, 1990
SYNERMED CHOLESTEROL REAGENT KIT
K903015 · CHH
Synermed, Inc.
Chemistry · 83d
Cleared Oct 01, 1990
TRIGLYCERIDES REAGENT GPO 5 X CONC.
K903897 · CDT
Trace Scientific , Ltd.
Chemistry · 39d
Cleared Sep 27, 1990
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
K902935 · JHM
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 27, 1990
KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN
K903071 · JJE
Eastman Kodak Company
Chemistry · 77d
Cleared Sep 27, 1990
TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
K903305 · KHS
Technicon Instruments Corp.
Chemistry · 65d
Cleared Sep 27, 1990
SYVA(R) ETS(R) PLUS SYSTEM
K903357 · JJF
Syva Co.
Chemistry · 63d
Cleared Sep 27, 1990
SYNERMED URIC ACID REAGENT KIT
K903727 · KNK
Synermed, Inc.
Chemistry · 42d
Cleared Sep 27, 1990
HI CHEM PROTEIN/LIPIDS LINEARITY
K903888 · JIX
Hichem Diagnostics
Chemistry · 36d
Cleared Sep 27, 1990
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
K903913 · JIX
Baxter Healthcare Corp
Chemistry · 34d