K934774 is an FDA 510(k) clearance for the UNKNOWN. This device is classified as a Epstein-barr Virus, Other (Class I - General Controls, product code LSE).
Submitted by Granbio, Inc. (Temecula, US). The FDA issued a Cleared decision on April 20, 1994, 197 days after receiving the submission on October 5, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K934774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1993 |
| Decision Date | April 20, 1994 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSE — Epstein-barr Virus, Other |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |