K010796 is an FDA 510(k) clearance for the AIA-PACK BRCA, ST AIA PACK BRCA. This device is classified as a System, Test, Immunological, Antigen, Tumor (Class II - Special Controls, product code MOI).
Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on August 16, 2001, 153 days after receiving the submission on March 16, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K010796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2001 |
| Decision Date | August 16, 2001 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MOI — System, Test, Immunological, Antigen, Tumor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |