K894932 is an FDA 510(k) clearance for the FIAX EB VCA-M TEST KIT. This device is classified as a Epstein-barr Virus, Other (Class I - General Controls, product code LSE).
Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on October 16, 1989, 74 days after receiving the submission on August 3, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K894932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1989 |
| Decision Date | October 16, 1989 |
| Days to Decision | 74 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 |