K061841 is an FDA 510(k) clearance for the QUANTA LITE INTRINSIC FACTOR ELISA. This device is classified as a Radioassay, Intrinsic Factor Blocking Antibody (Class II - Special Controls, product code LIG).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 22, 2006, 176 days after receiving the submission on June 29, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K061841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2006 |
| Decision Date | December 22, 2006 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LIG — Radioassay, Intrinsic Factor Blocking Antibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1810 |