The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Ebv-na Test.
| Device ID | K880043 |
| 510k Number | K880043 |
| Device Name: | EBV-NA TEST |
| Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
| Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Contact | Fred W Rachford,phd |
| Correspondent | Fred W Rachford,phd GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Product Code | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-06 |
| Decision Date | 1988-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101953 | K880043 | 000 |