Cleared Traditional

PATHODX HERPES TYPING

K904167 · Diagnostic Products Corp. · Microbiology
Dec 1990
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K904167 is an FDA 510(k) clearance for the PATHODX HERPES TYPING, a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQL), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 13, 1990, 93 days after receiving the submission on September 11, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K904167 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1990
Decision Date December 13, 1990
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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