K022178 is an FDA 510(k) clearance for the CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM. This device is classified as a System, Test, Immunological, Antigen, Tumor (Class II - Special Controls, product code MOI).
Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 12, 2002, 132 days after receiving the submission on July 3, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K022178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2002 |
| Decision Date | November 12, 2002 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| 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 |