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
6721–6744 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 30, 1990
FLAGEN TM FREE T4
K904539 · CEC
Cyberfluor, Inc.
Chemistry · 57d
Cleared Nov 28, 1990
BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT
K904184 · LBR
Biotron U.S.A., Inc.
Chemistry · 77d
Cleared Nov 28, 1990
STRATUS PRIMIDONE FLUOROMETRIC ENZYME
K904683 · LFT
Baxter Healthcare Corp
Chemistry · 44d
Cleared Nov 28, 1990
SECONDARY CALIBRATORS
K904698 · JIT
Bionostics, Inc.
Chemistry · 43d
Cleared Nov 28, 1990
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138
K905096 · JQB
Amresco, Inc.
Chemistry · 15d
Cleared Nov 21, 1990
MILENIA (TM) METHAMPHETAMINE
K904451 · DKZ
Diagnostic Products Corp.
Chemistry · 54d
Cleared Nov 20, 1990
KETONE TEST B SANWA STANDARD
K903366 · JIN
Ihara Medics U.S., Inc.
Chemistry · 117d
Cleared Nov 20, 1990
KETONE TEST A SANWA STANDARD
K903367 · JIN
Ihara Medics U.S., Inc.
Chemistry · 117d
Cleared Nov 20, 1990
CIBA CORNING ACS FSH IMMUNOASSAY
K904649 · CGJ
Ciba Corning Diagnostics Corp.
Chemistry · 40d
Cleared Nov 20, 1990
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
K904660 · JFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 36d
Cleared Nov 20, 1990
P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
K904761 · CIE
Instrumentation Laboratory CO
Chemistry · 32d
Cleared Nov 20, 1990
CEDIA (R) VITAMIN B12/FOLATE ASSAY
K904776 · CDD
Microgenics Corp.
Chemistry · 29d
Cleared Nov 09, 1990
REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
K904035 · LBT
Helena Laboratories
Chemistry · 70d
Cleared Nov 09, 1990
KODATROL I AND II CONTROL AND DILUENT SET
K904768 · JJY
Eastman Kodak Company
Chemistry · 18d
Cleared Nov 07, 1990
CIBA CORNING ACS PROLACTIN IMMUNOASSAY
K904714 · CFT
Ciba Corning Diagnostics Corp.
Chemistry · 20d
Cleared Nov 06, 1990
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
K903441 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 98d
Cleared Nov 06, 1990
REFLOTRON POTASSIUM TEST TABS
K904033 · CEJ
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Nov 06, 1990
BIOCLONES ELEGANCE LH ELISA KIT
K904387 · CEP
Bioclone Australia Pty , Ltd.
Chemistry · 42d
Cleared Nov 06, 1990
QMS TM- PHENYTOIN
K904815 · DIP
Seradyn, Inc.
Chemistry · 13d
Cleared Nov 05, 1990
ELEGANCE PROLACTIN ELISA
K904483 · CFT
Bioclone Australia Pty , Ltd.
Chemistry · 34d
Cleared Nov 02, 1990
SERACON CR REFERENCE
K904503 · JJX
Bhp Diagnostix, Inc.
Chemistry · 31d
Cleared Nov 02, 1990
AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
K904666 · JLW
Amersham Corp.
Chemistry · 18d
Cleared Nov 02, 1990
QUALICHECK 3
K904733 · JJS
Radiometer America, Inc.
Chemistry · 16d
Cleared Nov 01, 1990
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III
K904141 · JJY
Medical Analysis Systems, Inc.
Chemistry · 56d