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
6289–6312 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 11, 1992
MILES LIPASE SERA-PAK METHOD
K920337 · CHI
Heraeus Kulzer, Inc.
Chemistry · 47d
Cleared Mar 11, 1992
IMMULITE HLH
K920411 · CEP
Cirrus Diagnostics, Inc.
Chemistry · 40d
Cleared Mar 11, 1992
TRACE MAGNESIUM - ARSENAZO REAGENT
K920603 · JGJ
Trace America, Inc.
Chemistry · 39d
Cleared Mar 04, 1992
FIRST CHOICE
K912580 · CGA
Polymer Technology Corp.
Chemistry · 266d
Cleared Mar 04, 1992
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT
K920299 · CFL
Medix Biotech, Inc.
Chemistry · 42d
Cleared Mar 04, 1992
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
K920336 · CIT
Heraeus Kulzer, Inc.
Chemistry · 40d
Cleared Mar 02, 1992
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
K914886 · CGR
Serono-Baker Diagnostics, Inc.
Chemistry · 124d
Cleared Mar 02, 1992
SRI TESTOSTERONE ENZYME IMMUNOASSAY
K915164 · CDZ
Serono-Baker Diagnostics, Inc.
Chemistry · 109d
Cleared Mar 02, 1992
TSH CONTROL
K915325 · JJX
Polymedco, Inc.
Chemistry · 101d
Cleared Mar 02, 1992
ACTH IRMA KIT II MITSUBISHI YUKA
K915727 · CKG
Mitsubishi Yuka America, Inc.
Chemistry · 73d
Cleared Mar 02, 1992
AMERLITE MAB FT4 ASSAY
K920247 · CEC
Eastman Kodak Company
Chemistry · 41d
Cleared Mar 02, 1992
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K920504 · CEP
Medix Biotech, Inc.
Chemistry · 26d
Cleared Mar 02, 1992
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Feb 27, 1992
ACID PHOSPHATASE REAGENT SET
K915705 · CKE
Tech Intl. Co.
Chemistry · 90d
Cleared Feb 26, 1992
AMMONIA REAGENT SET
K915707 · JIF
Tech Intl. Co.
Chemistry · 89d
Cleared Feb 21, 1992
URIC ACID REAGENT SET
K914158 · KNK
Tech Intl. Co.
Chemistry · 157d
Cleared Feb 21, 1992
RSP MEGA SAMPLE PROCESSOR
K915492 · JQW
Tecan U.S., Ltd.
Chemistry · 79d
Cleared Feb 18, 1992
IL TEST(TM) AMLYLASE
K913744 · JFJ
Instrumentation Laboratory CO
Chemistry · 182d
Cleared Feb 18, 1992
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
K914135 · CFT
Amersham Corp.
Chemistry · 155d
Cleared Feb 18, 1992
MODEL 795 FLUOROMETER/DENSITOMETER
K915332 · JQT
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Feb 18, 1992
MICROPROTEIN-PR
K915380 · CEK
Sigma Diagnostics, Inc.
Chemistry · 81d
Cleared Feb 18, 1992
LIPASE REAGENT SET
K915706 · CET
Tech Intl. Co.
Chemistry · 81d
Cleared Feb 18, 1992
IMX ESTRADIOL
K920047 · CHP
Abbott Laboratories
Chemistry · 43d
Cleared Feb 18, 1992
AFFINITY PRG
K920230 · JLS
Bd Becton Dickinson Vacutainer...
Chemistry · 32d