Cleared Traditional

BARTELS CINAKIT CMV ANTIGENEMIA

K982311 · Intracel Corp. · Microbiology
Dec 1998
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K982311 is an FDA 510(k) clearance for the BARTELS CINAKIT CMV ANTIGENEMIA, a Antigen, Cf (including Cf Control), Cytomegalovirus (Class II — Special Controls, product code GQH), submitted by Intracel Corp. (Rockville, US). The FDA issued a Cleared decision on December 14, 1998, 166 days after receiving the submission on July 1, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K982311 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1998
Decision Date December 14, 1998
Days to Decision 166 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GQH — Antigen, Cf (including Cf Control), Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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