CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH— 510(k) K063647
Substantially EquivalentThermo Electron OY
FDA 510(k) clearance K063647 for CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH, Substantially Equivalent on 2007-03-12. Applicant: Thermo Electron OY. Device class: 2.
Clearance details
- Applicant
- Thermo Electron OY
- Product code
- Code NDY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vantaa, FI
Recent devices under product code NDY
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- K063131 — CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
- K063838 — LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
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