VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004— 510(k) K012120
Substantially EquivalentMaine Standards Co.
FDA 510(k) clearance K012120 for VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004, Substantially Equivalent on 2001-08-20. Applicant: Maine Standards Co.. Device class: 1.
Clearance details
- Applicant
- Maine Standards Co.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, ME, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.