TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS— 510(k) K062840
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K062840 for TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS, Substantially Equivalent on 2007-03-01. Applicant: Biosite Incorporated. Device class: 2.
Clearance details
- Applicant
- Biosite Incorporated
- 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
- San Diego, CA, US
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More clearances from Biosite Incorporated
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