The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Acs:180 Br (automated Chemiluminescence System For The Quantitation Of Cancer Antigen 27.29).
| Device ID | K970695 |
| 510k Number | K970695 |
| Device Name: | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) |
| Classification | System, Test, Immunological, Antigen, Tumor |
| Applicant | CHIRON DIAGNOSTICS CORP. 1401 HARBOR BAY PKWY. Alameda, CA 94501 |
| Contact | Diane C Oates |
| Correspondent | Diane C Oates CHIRON DIAGNOSTICS CORP. 1401 HARBOR BAY PKWY. Alameda, CA 94501 |
| Product Code | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-25 |
| Decision Date | 1997-08-08 |
| Summary: | summary |