The following data is part of a premarket notification filed by Chemicon Intl., Inc. with the FDA for Coxsackievirus B Blend Monoclonal Antibodies.
Device ID | K940471 |
510k Number | K940471 |
Device Name: | COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES |
Classification | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 |
Applicant | CHEMICON INTL., INC. 28835 SINGLE OAK DR. Temecula, CA 92590 |
Contact | Richard P Triglia |
Correspondent | Richard P Triglia 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 | 1994-02-02 |
Decision Date | 1995-09-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04053252734557 | K940471 | 000 |
04053252729225 | K940471 | 000 |
04053252404290 | K940471 | 000 |
04061841171218 | K940471 | 000 |