VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126— 510(k) K033879
Substantially EquivalentMaine Standards Co.
FDA 510(k) clearance K033879 for VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126, Substantially Equivalent on 2004-02-27. Applicant: Maine Standards Co.. Device class: 2.
Clearance details
- Applicant
- Maine Standards Co.
- Product code
- Code DKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, ME, US
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