Cleared Traditional

MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST

K880157 · Syva Co. · Microbiology
Feb 1988
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K880157 is an FDA 510(k) clearance for the MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST, a Antigen, Cf (including Cf Control), Rubella (Class II — Special Controls, product code GON), submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on February 4, 1988, 22 days after receiving the submission on January 13, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K880157 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1988
Decision Date February 04, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GON — Antigen, Cf (including Cf Control), Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510