Cleared Traditional

THE DDI SERODOT HERPES IGG TEST KIT

K875366 · Disease Detection International, Inc. · Microbiology
May 1988
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K875366 is an FDA 510(k) clearance for the THE DDI SERODOT HERPES IGG TEST KIT, a Antisera, Cf, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQO), submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on May 23, 1988, 144 days after receiving the submission on December 31, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K875366 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1987
Decision Date May 23, 1988
Days to Decision 144 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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