Cleared Traditional

PATHODX CYTOMEGALOVIRUS

K934798 · Diagnostic Products Corp. · Microbiology
Mar 1994
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K934798 is an FDA 510(k) clearance for the PATHODX CYTOMEGALOVIRUS, a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 25, 1994, 169 days after receiving the submission on October 7, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K934798 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1993
Decision Date March 25, 1994
Days to Decision 169 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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