QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)— 510(k) K023335

Name: FDA 510(k) clearance K023335
Creator: U.S. Food and Drug Administration
Published: 2003-06-18

Substantially Equivalent

Qc Sciences, LLC

FDA 510(k) clearance K023335 for QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010), Substantially Equivalent on 2003-06-18. Applicant: Qc Sciences, LLC. Device class: 2.

Clearance details

Applicant: Qc Sciences, LLC
Product code: Code NJW
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2002-10-07
Decision date: 2003-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

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