ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS

Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

CHEMICON INTL., INC.

The following data is part of a premarket notification filed by Chemicon Intl., Inc. with the FDA for Enterovirus Monocl Antibody Det Of Coxsackie A9 Virus.

Pre-market Notification Details

• Device ID: K936073
• 510k Number: K936073
• Device Name: ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS
• Classification: Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
• Applicant: CHEMICON INTL., INC. 28835 SINGLE OAK DR. Temecula, CA 92590
• Contact: Priscilla Zia
• Correspondent: Priscilla Zia; CHEMICON INTL., INC. 28835 SINGLE OAK DR. Temecula, CA 92590
• Product Code: GNM
• CFR Regulation Number: 866.3145 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-12-20
• Decision Date: 1995-09-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04053252672989	K936073	000
04061841171737	K936073	000