LYPHOCHEK HEMOSTASIS CONTROL— 510(k) K040275
Substantially EquivalentBio-Rad
FDA 510(k) clearance K040275 for LYPHOCHEK HEMOSTASIS CONTROL, Substantially Equivalent on 2004-02-27. Applicant: Bio-Rad. Device class: 2.
Clearance details
- Applicant
- Bio-Rad
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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More clearances from Bio-Rad
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