The following data is part of a premarket notification filed by Chemicon Intl., Inc. with the FDA for Coxsackie A24 Virus Monoclonal Antibody.
Device ID | K936089 |
510k Number | K936089 |
Device Name: | COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY |
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 | 1993-12-21 |
Decision Date | 1995-09-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04053252326011 | K936089 | 000 |