K970695 is an FDA 510(k) clearance for the ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29). This device is classified as a System, Test, Immunological, Antigen, Tumor (Class II - Special Controls, product code MOI).
Submitted by Chiron Diagnostics Corp. (Alameda, US). The FDA issued a Cleared decision on August 8, 1997, 164 days after receiving the submission on February 25, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K970695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1997 |
| Decision Date | August 08, 1997 |
| Days to Decision | 164 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 |