LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL— 510(k) K063705
Substantially EquivalentThermo Electron OY
FDA 510(k) clearance K063705 for LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL, Substantially Equivalent on 2007-10-09. Applicant: Thermo Electron OY. Device class: 2.
Clearance details
- Applicant
- Thermo Electron OY
- Product code
- Code NDW
- Device class
- Class 2
- Regulation
- 21 CFR 862.3560
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vantaa, FI
Recent devices under product code NDW
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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
- K063086 — TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
- K063209 — HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.