K971335 is an FDA 510(k) clearance for the QUANTA LITE CMV IGG ELISA. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II - Special Controls, product code LFZ).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 1, 1997, 235 days after receiving the submission on April 10, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K971335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1997 |
| Decision Date | December 01, 1997 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |