ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)— 510(k) K970695
Substantially EquivalentChiron Diagnostics Corp.
FDA 510(k) clearance K970695 for ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29), Substantially Equivalent on 1997-08-08. Applicant: Chiron Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Chiron Diagnostics Corp.
- Product code
- Code MOI
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code MOI
view allMore clearances from Chiron Diagnostics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.