K971304 is an FDA 510(k) clearance for the QUANTA LITE REBELLA IGG. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II - Special Controls, product code LFX).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 2, 1998, 269 days after receiving the submission on April 8, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K971304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1997 |
| Decision Date | January 02, 1998 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LFX — Enzyme Linked Immunoabsorbent Assay, Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |