I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02— 510(k) K071319
Substantially EquivalentBio-Rad, Diagnostics Grp.
FDA 510(k) clearance K071319 for I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02, Substantially Equivalent on 2007-06-26. Applicant: Bio-Rad, Diagnostics Grp..
Clearance details
- Applicant
- Bio-Rad, Diagnostics Grp.
- Product code
- Code GGN
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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