Cleared Traditional

K811021 - HERPES
(FDA 510(k) Clearance)

K811021 · Immuno-Diagnostic Products, Inc. · Microbiology

Nov 1981

Decision

204d

Days

Class 2

Risk

K811021 is an FDA 510(k) clearance for the HERPES. This device is classified as a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQN).

Submitted by Immuno-Diagnostic Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1981, 204 days after receiving the submission on April 15, 1981.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K811021 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1981
Decision Date	November 05, 1981
Days to Decision	204 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—