EMIT DISOPYRAMIDE ASSAY

Enzyme Immunoassay, Lidocaine

SYVA CO.

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

Pre-market Notification Details

• Device ID: K801204
• 510k Number: K801204
• Device Name: EMIT DISOPYRAMIDE ASSAY
• Classification: Enzyme Immunoassay, Lidocaine
• Applicant: SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KLR
• CFR Regulation Number: 862.3555 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-05-19
• Decision Date: 1980-06-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001406	K801204	000