MODIFICA-OF EMIT AED PRIMIDONE ASSAY

Enzyme Immunoassay, Primidone

SYVA CO.

The following data is part of a premarket notification filed by Syva Co. with the FDA for Modifica-of Emit Aed Primidone Assay.

Pre-market Notification Details

• Device ID: K832798
• 510k Number: K832798
• Device Name: MODIFICA-OF EMIT AED PRIMIDONE ASSAY
• Classification: Enzyme Immunoassay, Primidone
• Applicant: SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DJD
• CFR Regulation Number: 862.3680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-08-18
• Decision Date: 1983-10-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001376	K832798	000