Her-2, ER, PR IHControls— 510(k) K220163

Name: FDA 510(k) clearance K220163
Creator: U.S. Food and Drug Administration
Published: 2022-08-15

Substantially Equivalent

Boston Cell Standards, Inc.

FDA 510(k) clearance K220163 for Her-2, ER, PR IHControls, Substantially Equivalent on 2022-08-15. Applicant: Boston Cell Standards, Inc.. Device class: 2.

Clearance details

Applicant: Boston Cell Standards, Inc.
Product code: Code NJW
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2022-01-20
Decision date: 2022-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sharon, MA, US

Download summary PDF View on FDA.gov ↗

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