K881617 is an FDA 510(k) clearance for the INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY. 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 June 7, 1988, 53 days after receiving the submission on April 15, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K881617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1988 |
| Decision Date | June 07, 1988 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LSE — Epstein-barr Virus, Other |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3235 |