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510(k) K050374

ADVIA IMS LITHIUM ASSAY by Bayer Healthcare, LLC — Product Code NDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2005
Date Received
February 14, 2005
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

  • K243462 — Diazyme Colorimetric Lithium Assay (August 1, 2025)
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  • K063684 — COBAS LITHIUM (March 21, 2008)
  • K063705 — LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CA (October 9, 2007)
  • K070987 — SENTINEL LITHIUM ASSAY (August 2, 2007)
  • K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (January 17, 2001)