K903218 is an FDA 510(k) clearance for the IMX B12. This device is classified as a Radioassay, Intrinsic Factor Blocking Antibody (Class II - Special Controls, product code LIG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 23, 1990, 31 days after receiving the submission on July 23, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K903218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1990 |
| Decision Date | August 23, 1990 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LIG — Radioassay, Intrinsic Factor Blocking Antibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1810 |