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
4705–4728 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 18, 1996
ISOLAB'S T4 TEST KIT
K951014 · KLI
Isolab, Inc.
Chemistry · 592d
Cleared Oct 18, 1996
VITROS IMMUNODIAGNOSTIC SYSTEM
K962919 · KHO
Johnson & Johnson Clinical...
Chemistry · 84d
Cleared Oct 18, 1996
VISUALINE D HCG
K963408 · JHI
Sun Biomedical Laboratories, Inc.
Chemistry · 50d
Cleared Oct 15, 1996
HEMOCUE B-GLCOSE SYSTEM
K962415 · LFR
Hemocue, Inc.
Chemistry · 125d
Cleared Oct 15, 1996
CIBA CORNING ACS
K963251 · JMM
Ciba Corning Diagnostics Corp.
Chemistry · 57d
Cleared Oct 11, 1996
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
K963538 · JFL
Sigma Diagnostics, Inc.
Chemistry · 37d
Cleared Oct 10, 1996
SIGMA DIAGNOSTICS CALICIUM REAGENT
K963536 · CJY
Sigma Diagnostics, Inc.
Chemistry · 37d
Cleared Oct 08, 1996
SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE...
K962464 · JLW
Scantibodies Laboratory, Inc.
Chemistry · 105d
Cleared Oct 07, 1996
BIO-CSF LIQUID CONTROL LEVEL 1 AND 2
K963551 · JJX
Biocell Laboratories, Inc.
Chemistry · 32d
Cleared Oct 01, 1996
EVIDENCE PREGNANCY TEST
K962721 · LCX
Saliva Diagnostic Systems
Chemistry · 78d
Cleared Oct 01, 1996
MANUAL PHENYLALANINE TEST
K963040 · JNB
Bio-Rad
Chemistry · 57d
Cleared Sep 30, 1996
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
K963534 · CGX
Sigma Diagnostics, Inc.
Chemistry · 26d
Cleared Sep 27, 1996
ROCHE UNIMATE FRUCTOSAMINE REAGENT
K961674 · LCP
Roche Diagnostic Systems, Inc.
Chemistry · 149d
Cleared Sep 27, 1996
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
K962033 · CEW
Nichols Institute Diagnostics
Chemistry · 126d
Cleared Sep 27, 1996
CUSTOMED BLOOD EXTRACTION KIT
K962596 · GJE
Customed, Inc.
Chemistry · 87d
Cleared Sep 27, 1996
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
K962890 · CHH
Trace Scientific , Ltd.
Chemistry · 65d
Cleared Sep 27, 1996
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC...
K963080 · CDZ
Bayer Corp.
Chemistry · 50d
Cleared Sep 27, 1996
DCA 2000 + MICROALBUMIN/CREATININE ASSAY
K963142 · JIR
Bayer Corp.
Chemistry · 45d
Cleared Sep 27, 1996
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
K963540 · JFL
Sigma Diagnostics, Inc.
Chemistry · 23d
Cleared Sep 27, 1996
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
K963542 · JGS
Sigma Diagnostics, Inc.
Chemistry · 23d
Cleared Sep 25, 1996
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
K953567 · MRG
Incstar Corp.
Chemistry · 422d
Cleared Sep 24, 1996
AMD HOME HEALTH MONITORING SYSTEM
K960337 · CGA
Advanced Medical Devices, Inc.
Chemistry · 244d
Cleared Sep 23, 1996
AFFIRM ONE-STEP HOME PREGNANCY TEST
K962888 · LCX
Athena Medical Corp.
Chemistry · 61d
Cleared Sep 23, 1996
HICHEM ALP/AMP REAGENT KIT
K963383 · CKF
Hichem Diagnostics
Chemistry · 27d