EMIT-TOX SERUM CALIBRATORS

Calibrators, Drug Mixture

SYVA CO.

The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit-tox Serum Calibrators.

Pre-market Notification Details

• Device ID: K811620
• 510k Number: K811620
• Device Name: EMIT-TOX SERUM CALIBRATORS
• Classification: Calibrators, Drug Mixture
• Applicant: SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DKB
• CFR Regulation Number: 862.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-06-08
• Decision Date: 1981-06-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001574	K811620	000