K033603 is an FDA 510(k) clearance for the INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999. 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 December 19, 2003, 32 days after receiving the submission on November 17, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K033603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2003 |
| Decision Date | December 19, 2003 |
| Days to Decision | 32 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 |