EMIT-AND METHOTREXATE ASSAY

Enzyme Immunoassay, Methotrexate

SYVA CO.

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

Pre-market Notification Details

• Device ID: K811459
• 510k Number: K811459
• Device Name: EMIT-AND METHOTREXATE ASSAY
• Classification: Enzyme Immunoassay, Methotrexate
• Applicant: SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: LAO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-05-26
• Decision Date: 1981-06-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001383	K811459	000