Home / 510(k) Clearances / K063705

510(k) K063705

LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL by Thermo Electron OY — Product Code NDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2007
Date Received
December 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Porphyrin, Spectrophotometry, Lithium
Device Class
Class II
Regulation Number
862.3560
Review Panel
TX
Submission Type

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Other clearances for product code NDW

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  • K050374 — ADVIA IMS LITHIUM ASSAY (June 15, 2005)
  • K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (January 17, 2001)