510(k) K970695
K970695 is an FDA 510(k) premarket notification submitted by Chiron Diagnostics Corp. for the device "ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)". The FDA issued a decision of Substantially Equivalent on August 8, 1997. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Chiron Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 1997
- Date Received
- February 25, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Immunological, Antigen, Tumor
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type