Cleared Traditional

K851635 - DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
(FDA 510(k) Clearance)

K851635 · Diagnon Corp. · Microbiology

Oct 1985

Decision

175d

Days

Class 2

Risk

K851635 is an FDA 510(k) clearance for the DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST, a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQL), submitted by Diagnon Corp. (Laurel, US). The FDA issued a Cleared decision on October 10, 1985, 175 days after receiving the submission on April 18, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K851635 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 1985
Decision Date	October 10, 1985
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—