REVISED LABELING FOR SYVA BARBITURATE ASSAYS

Enzyme Immunoassay, Barbiturate

SYVA CO.

The following data is part of a premarket notification filed by Syva Co. with the FDA for Revised Labeling For Syva Barbiturate Assays.

Pre-market Notification Details

• Device ID: K874702
• 510k Number: K874702
• Device Name: REVISED LABELING FOR SYVA BARBITURATE ASSAYS
• Classification: Enzyme Immunoassay, Barbiturate
• Applicant: SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303
• Contact: Eleanor V Chiu
• Correspondent: Eleanor V Chiu; SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303
• Product Code: DIS
• CFR Regulation Number: 862.3150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-11-16
• Decision Date: 1988-01-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001604	K874702	000