K070317 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC VZV IGM 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 5, 2007, 153 days after receiving the submission on February 2, 2007.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.
| 510(k) Number | K070317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2007 |
| Decision Date | July 05, 2007 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3900 |