QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)


Device Classification Name

control material, her-2/neu, immunohistochemistry

510(k) Number K023335
Device Name QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
Original Applicant
QC SCIENCES, LLC
2807 n. parham
suite 114
richmond, 
VA 
23294

Original Contact junqi qian
Regulation Number 864.1860
Classification Product Code
NJW  
Date Received 10/07/2002
Decision Date 06/18/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Pathology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No