K951822 is an FDA 510(k) clearance for the EBNA ENZYME IMMUNOASSAY KIT. This device is classified as a Test, Antigen, Nuclear, Epstein-barr Virus (Class I - General Controls, product code LLM).
Submitted by Granbio, Inc. (Temecula, US). The FDA issued a Cleared decision on February 15, 1996, 301 days after receiving the submission on April 20, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K951822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1995 |
| Decision Date | February 15, 1996 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LLM — Test, Antigen, Nuclear, Epstein-barr Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |