Cleared Traditional

CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

K951821 · Light Diagnostics · Microbiology
Jun 1996
Decision
414d
Days
Class 2
Risk

About This 510(k) Submission

K951821 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY, a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN), submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on June 7, 1996, 414 days after receiving the submission on April 20, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K951821 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 1995
Decision Date June 07, 1996
Days to Decision 414 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIN — Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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