EMIT ANTIEPILEPTIC DRUG CALIBRATORS

Calibrator, Primary

SYVA CO.

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

Pre-market Notification Details

• Device ID: K780467
• 510k Number: K780467
• Device Name: EMIT ANTIEPILEPTIC DRUG CALIBRATORS
• Classification: Calibrator, Primary
• Applicant: SYVA CO. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: JIS
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-03-22
• Decision Date: 1978-04-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768001253	K780467	000