AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT

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 Amendment To Labeling Microtrak Hsv 1/hsv 2 Direct.

Pre-market Notification Details

• Device ID: K850739
• 510k Number: K850739
• Device Name: AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT
• Classification: Antisera, Fluorescent, Herpesvirus Hominis 1,2
• Applicant: SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303
• Contact: Joan Kurjian
• Correspondent: Joan Kurjian; SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303
• Product Code: GQL
• CFR Regulation Number: 866.3305 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-02-15
• Decision Date: 1985-03-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391516748643	K850739	000