The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Ebv(epstein-barr Virus) Test Kit.
| Device ID | K854207 |
| 510k Number | K854207 |
| Device Name: | EBV(EPSTEIN-BARR VIRUS) TEST KIT |
| Classification | Antiserum, Cf, Epstein-barr Virus |
| Applicant | IMMUNO-DIAGNOSTIC PRODUCTS, INC. P.O. BOX 193 54 SOUTH 130 EAST North Salt Lake, UT 84054 |
| Contact | Nadeem M Muna |
| Correspondent | Nadeem M Muna IMMUNO-DIAGNOSTIC PRODUCTS, INC. P.O. BOX 193 54 SOUTH 130 EAST North Salt Lake, UT 84054 |
| Product Code | GNP |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-16 |
| Decision Date | 1986-04-24 |