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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
10753–10776 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 20, 1982
URIC ACID REAGENT
K822913 · KNK
Ac Biochemical Laboratories, Inc.
Chemistry · 80d
Cleared Dec 15, 1982
AMES TDA GENTAMICIN TEST
K821669 · DJB
Miles Laboratories, Inc.
Chemistry · 191d
Cleared Dec 15, 1982
DSL 1700
K822897 · JHW
Diagnostic Systems Laboratories, Inc.
Chemistry · 78d
Cleared Dec 15, 1982
BIO MAG FREE T4 RADIOIMMUNOASSAY KIT
K823005 · CEC
Bioclinical Group
Chemistry · 64d
Cleared Dec 15, 1982
FREE & TOTAL ESTRIOL KIT
K823202 · CGI
Diagnostic Products Corp.
Chemistry · 50d
Cleared Dec 15, 1982
COUNT-10 STAIN
K823363 · LEE
V-Tech, Inc.
Chemistry · 36d
Cleared Dec 15, 1982
COUNT-10 SYSTEM FOR STAND. URINALYSIS
K823364 · JQW
V-Tech, Inc.
Chemistry · 36d
Cleared Dec 13, 1982
YSI MODEL 23L LACTATE ANALYZER
K822812 · HHP
Yellow Springs Instrument Co., Inc.
Chemistry · 84d
Cleared Dec 09, 1982
DSL 1600
K822898 · CIA
Diagnostic Systems Laboratories, Inc.
Chemistry · 71d
Cleared Dec 09, 1982
INNOTRON FLUORIMETER SERIES ONE-10
K822942 · KHO
Innotron of Oregon, Inc.
Chemistry · 66d
Cleared Dec 09, 1982
KM-KAL L3
K823044 · JIX
Kmn Products, Inc.
Chemistry · 55d
Cleared Dec 09, 1982
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265 · CDX
Bd Becton Dickinson Vacutainer...
Chemistry · 37d
Cleared Dec 09, 1982
CHOLESTEROL CHOD-PAP TEST
K823302 · CHH
Boehringer Mannheim Corp.
Chemistry · 34d
Cleared Dec 09, 1982
PRISMA C-REACTIVE PROTEIN CONTROLS
K823415 · DCK
Syva Co.
Chemistry · 24d
Cleared Dec 09, 1982
PRISMA-C-REACTIVE PROTEIN CALIBRATORS
K823417 · DCK
Syva Co.
Chemistry · 24d
Cleared Dec 03, 1982
BLOOD GAS EXPER. SYSTEM 8700
K822778 · JQP
Exper Corp., Inc.
Chemistry · 80d
Cleared Dec 03, 1982
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
K822867 · LCP
Isolab, Inc.
Chemistry · 67d
Cleared Dec 03, 1982
LIQUIZYME CALCIUM REAGENT SET
K823219 · CIC
American Research Products Co.
Chemistry · 36d
Cleared Dec 03, 1982
CAP-RIA 16
K823240 · JJJ
Capintec, Inc.
Chemistry · 32d
Cleared Dec 03, 1982
AUTOPAK FERRITIN TEST DELIVERY SYS
K823275 · DBF
Micromedic Systems
Chemistry · 30d
Cleared Nov 29, 1982
ADVANCE EMIT CAD PROCAINAMIDE ASSAY
K823128 · LAR
Syva Co.
Chemistry · 35d
Cleared Nov 29, 1982
ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE
K823129 · LAN
Syva Co.
Chemistry · 35d
Cleared Nov 29, 1982
SINGLE STEP FREE-T4 125I RADIOIMMUNO-
K823144 · CEC
Corning Medical & Scientific
Chemistry · 35d
Cleared Nov 29, 1982
LIQUIZYME TOTAL PROTEIN REAGENT
K823170 · CEK
Amresco, Inc.
Chemistry · 34d