BARTELS CINAKIT CMV ANTIGENEMIA— 510(k) K982311

Substantially Equivalent

Intracel Corp.

FDA 510(k) clearance K982311 for BARTELS CINAKIT CMV ANTIGENEMIA, Substantially Equivalent on 1998-12-14. Applicant: Intracel Corp.. Device class: 2.

Clearance details

Applicant: Intracel Corp.
Product code: Code GQH
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1998-07-01
Decision date: 1998-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.