MICROTRAK HSV 1 & 2 DIRECT SPECIMAN

Antisera, Fluorescent, Herpesvirus Hominis 1,2

SYVA CO.

The following data is part of a premarket notification filed by Syva Co. with the FDA for Microtrak Hsv 1 & 2 Direct Speciman.

Pre-market Notification Details

• Device ID: K841190
• 510k Number: K841190
• Device Name: MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
• Classification: Antisera, Fluorescent, Herpesvirus Hominis 1,2
• Applicant: SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GQL
• CFR Regulation Number: 866.3305 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-03-21
• Decision Date: 1985-01-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391516746038	K841190	000