REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS

Enzyme Immunoassay, Benzodiazepine

SYVA CO.

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

Pre-market Notification Details

• Device ID: K874376
• 510k Number: K874376
• Device Name: REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
• Classification: Enzyme Immunoassay, Benzodiazepine
• 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: JXM
• CFR Regulation Number: 862.3170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-10-26
• Decision Date: 1987-11-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001581	K874376	000