FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2— 510(k) K932657
Substantially EquivalentMore Diagnostics
FDA 510(k) clearance K932657 for FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2, Substantially Equivalent on 1993-11-02. Applicant: More Diagnostics. Device class: 2.
Clearance details
- Applicant
- More Diagnostics
- Product code
- Code DAP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Osos, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.