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 |