K854207 is an FDA 510(k) clearance for the EBV(EPSTEIN-BARR VIRUS) TEST KIT. This device is classified as a Antiserum, Cf, Epstein-barr Virus (Class I - General Controls, product code GNP).
Submitted by Immuno-Diagnostic Products, Inc. (North Salt Lake, US). The FDA issued a Cleared decision on April 24, 1986, 190 days after receiving the submission on October 16, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K854207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1985 |
| Decision Date | April 24, 1986 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GNP — Antiserum, Cf, Epstein-barr Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |