Cleared Traditional

INDIRECT FLUORESCENT ASSAY FOR (HCMV)

K882835 · Stellar Bio Systems, Inc. · Microbiology
Dec 1988
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K882835 is an FDA 510(k) clearance for the INDIRECT FLUORESCENT ASSAY FOR (HCMV), a Antigen, Cf (including Cf Control), Cytomegalovirus (Class II — Special Controls, product code GQH), submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on December 5, 1988, 150 days after receiving the submission on July 8, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K882835 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1988
Decision Date December 05, 1988
Days to Decision 150 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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