LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC— 510(k) K072721
Substantially EquivalentBio-Rad, Diagnostics Grp.
FDA 510(k) clearance K072721 for LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC, Substantially Equivalent on 2007-12-11. Applicant: Bio-Rad, Diagnostics Grp.. Device class: 1.
Clearance details
- Applicant
- Bio-Rad, Diagnostics Grp.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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