Cleared Traditional

CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY

K935809 · Light Diagnostics · Microbiology
May 1994
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K935809 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY, a Antigen, Cf (including Cf Control), Cytomegalovirus (Class II — Special Controls, product code GQH), submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on May 5, 1994, 154 days after receiving the submission on December 2, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K935809 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1993
Decision Date May 05, 1994
Days to Decision 154 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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