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
5569–5592 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 26, 1994
MULTICHECK(TM)
K935515 · JJS
Radiometer America, Inc.
Chemistry · 162d
Cleared Apr 26, 1994
SYNERMED IR 500 CHEMISTRY ANALYZER
K935662 · JIQ
Synermed, Inc.
Chemistry · 151d
Cleared Apr 26, 1994
IMMULITE DHEA-S04
K935806 · JKC
Diagnostic Products Corp.
Chemistry · 145d
Cleared Apr 26, 1994
SYSTEM WASHER 100
K936258 · JQW
Eg&G Berthold
Chemistry · 117d
Cleared Apr 26, 1994
CIBA CORNING ACS FT3 IMMUNOASSAY
K940482 · CEC
Ciba Corning Diagnostics Corp.
Chemistry · 83d
Cleared Apr 26, 1994
CEDIA T4 MAB ASSAY
K941042 · KLI
Microgenics Corp.
Chemistry · 50d
Cleared Apr 26, 1994
TECHNISON AXON SYSTEM
K941156 · KHS
Miles, Inc.
Chemistry · 47d
Cleared Apr 26, 1994
SYNERMED ISE REAGENTS
K941400 · JGS
Synermed, Inc.
Chemistry · 35d
Cleared Apr 25, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
K932728 · KNK
Eastman Kodak Company
Chemistry · 322d
Cleared Apr 25, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
K934413 · CIT
Eastman Kodak Company
Chemistry · 227d
Cleared Apr 21, 1994
SYNERMEDIR CAL I AND SYNERMED IR CAL II
K940571 · JIX
Synermed, Inc.
Chemistry · 72d
Cleared Apr 20, 1994
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K940272 · JJX
Analytical Control Systems, Inc.
Chemistry · 98d
Cleared Apr 20, 1994
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K940570 · CIG
Synermed, Inc.
Chemistry · 71d
Cleared Apr 15, 1994
ONE STEP PREGNANCY TEST
K936031 · JHI
Teco Diagnostics
Chemistry · 119d
Cleared Apr 13, 1994
AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM
K934124 · JQW
Andronic Devices, Ltd.
Chemistry · 231d
Cleared Apr 12, 1994
DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS
K933682 · JFJ
Miles, Inc.
Chemistry · 257d
Cleared Apr 12, 1994
BIOSCAN REAGENT STRIPS
K940043 · JIL
Bioscan Instruments, Inc.
Chemistry · 97d
Cleared Apr 11, 1994
JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT
K925468 · GJE
J.J. Skinner, Inc.
Chemistry · 529d
Cleared Apr 08, 1994
KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION
K936138 · JHI
Eastman Kodak Company
Chemistry · 106d
Cleared Apr 08, 1994
KODAK SURECELL HCG URINE TEST, MODIFICATION
K936287 · JHI
Eastman Kodak Company
Chemistry · 106d
Cleared Apr 06, 1994
AMYLASE
K930678 · JFJ
Horizon Diagnostics, Inc.
Chemistry · 421d
Cleared Apr 06, 1994
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR
K934592 · JJG
Abaxis, Inc.
Chemistry · 194d
Cleared Apr 06, 1994
URINARY/CEREBROSPINAL FLUID PROTEIN
K934841 · CEK
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 180d
Cleared Apr 06, 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
K935119 · JLW
Bio-Rad
Chemistry · 161d