Cleared Traditional

K802939 - HERPES SIMPLEX TYPE I
(FDA 510(k) Clearance)

K802939 · Orion Diagnostica, Inc. · Microbiology

Dec 1980

Decision

42d

Days

Class 2

Risk

K802939 is an FDA 510(k) clearance for the HERPES SIMPLEX TYPE I. This device is classified as a Antigen, Cf (including Cf Control), Rubella (Class II — Special Controls, product code GON).

Submitted by Orion Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1980, 42 days after receiving the submission on November 19, 1980.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K802939 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 1980
Decision Date	December 31, 1980
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—