The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Coxsackievirus B@ Monoclonal Antibody.
| Device ID | K936252 |
| 510k Number | K936252 |
| Device Name: | COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY |
| Classification | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 |
| Applicant | LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Priscilla Zia, Ph.d. |
| Correspondent | Priscilla Zia, Ph.d. LIGHT DIAGNOSTICS 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 | 1993-12-30 |
| Decision Date | 1995-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252516092 | K936252 | 000 |