K823805 is an FDA 510(k) clearance for the VARICELISA TEST KIT. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II - Special Controls, product code LFY).
Submitted by M.A. Bioproducts (Mchenry, US). The FDA issued a Cleared decision on May 5, 1983, 139 days after receiving the submission on December 17, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.
| 510(k) Number | K823805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1982 |
| Decision Date | May 05, 1983 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3900 |