K961012 is an FDA 510(k) clearance for the VZV IGG ELISA TEST SYSTEM. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II - Special Controls, product code LFY).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on July 24, 1996, 133 days after receiving the submission on March 13, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.
| 510(k) Number | K961012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 1996 |
| Decision Date | July 24, 1996 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3900 |