The following data is part of a premarket notification filed by Microbiological Research Corp. with the FDA for The Golden Quad Test (ebv).
| Device ID | K861121 |
| 510k Number | K861121 |
| Device Name: | THE GOLDEN QUAD TEST (EBV) |
| Classification | Antiserum, Cf, Epstein-barr Virus |
| Applicant | MICROBIOLOGICAL RESEARCH CORP. P.O. BOX 308 Bountiful, UT 84010 |
| Contact | Carole A Golden |
| Correspondent | Carole A Golden MICROBIOLOGICAL RESEARCH CORP. P.O. BOX 308 Bountiful, UT 84010 |
| Product Code | GNP |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-25 |
| Decision Date | 1987-02-02 |