HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL— 510(k) K063209
Substantially EquivalentThermo Electron OY
FDA 510(k) clearance K063209 for HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL, Substantially Equivalent on 2007-03-21. Applicant: Thermo Electron OY. Device class: 2.
Clearance details
- Applicant
- Thermo Electron OY
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vantaa, FI
Recent devices under product code LCP
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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
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