LYPHOCHEK DIABETES CONTROL— 510(k) K070546
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K070546 for LYPHOCHEK DIABETES CONTROL, Substantially Equivalent on 2007-04-02. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code GGM
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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