EMIT CAFFEINE CONTROL

Drug Specific Control Materials

SYVA / A SYNTEX CO.

The following data is part of a premarket notification filed by Syva / A Syntex Co. with the FDA for Emit Caffeine Control.

Pre-market Notification Details

• Device ID: K861511
• 510k Number: K861511
• Device Name: EMIT CAFFEINE CONTROL
• Classification: Drug Specific Control Materials
• Applicant: SYVA / A SYNTEX CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303
• Contact: Joan Kurjian
• Correspondent: Joan Kurjian; SYVA / A SYNTEX CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303
• Product Code: LAS
• CFR Regulation Number: 862.3280 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-04-23
• Decision Date: 1986-06-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001420	K861511	000