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510(k) K082001

DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B by Diazyme Laboratories — Product Code JII

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2008
Date Received
July 14, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Atomic Absorption, Lithium
Device Class
Class II
Regulation Number
862.3560
Review Panel
TX
Submission Type

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Other clearances for product code JII

  • K033360 — DIAZYME LITHIUM ENZYMATIC ASSAY KIT (December 23, 2003)
  • K912244 — UROTEST GPH (November 22, 1991)