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510(k) K243462

Diazyme Colorimetric Lithium Assay by Diazyme Laboratories, Inc. — Product Code NDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2025
Date Received
November 8, 2024
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

  • K112142 — DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE (November 4, 2011)
  • 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)
  • K050374 — ADVIA IMS LITHIUM ASSAY (June 15, 2005)
  • K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (January 17, 2001)