K072612 is an FDA 510(k) clearance for the ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647. This device is classified as a System, Test, Immunological, Antigen, Tumor (Class II - Special Controls, product code MOI).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on October 26, 2007, 39 days after receiving the submission on September 17, 2007.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K072612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2007 |
| Decision Date | October 26, 2007 |
| Days to Decision | 39 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MOI — System, Test, Immunological, Antigen, Tumor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |