The following data is part of a premarket notification filed by Chemicon Intl., Inc. with the FDA for Enterovirus 71 Monoclonal Antibody.
| Device ID | K940473 |
| 510k Number | K940473 |
| Device Name: | ENTEROVIRUS 71 MONOCLONAL ANTIBODY |
| Classification | Antisera, Fluorescent, Poliovirus 1-3 |
| 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 | GOE |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1995-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252469404 | K940473 | 000 |