K875170 is an FDA 510(k) clearance for the EBNA ANTIBODY. This device is classified as a Test, Antigen, Nuclear, Epstein-barr Virus (Class I - General Controls, product code LLM).
Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on May 23, 1988, 158 days after receiving the submission on December 17, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K875170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1987 |
| Decision Date | May 23, 1988 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LLM — Test, Antigen, Nuclear, Epstein-barr Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |