K240800 is an FDA 510(k) clearance for the Access Intrinsic Factor Ab. This device is classified as a Radioassay, Intrinsic Factor Blocking Antibody (Class II - Special Controls, product code LIG).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 3, 2024, 39 days after receiving the submission on March 25, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K240800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2024 |
| Decision Date | May 03, 2024 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LIG — Radioassay, Intrinsic Factor Blocking Antibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1810 |