510(k) K823363

Device: Count-10 Stain
Applicant: V-TECH, INC.
510(k) number: K823363
Product code: LEE
Decision: Substantially Equivalent (SESE)
Decision date: 1982-12-15
Date received: 1982-11-09
Regulation: 864.1850
Classification name: Stains, Dye Solution
Medical specialty: Hematology
Review panel: Hematology
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA