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510(k) K033360

DIAZYME LITHIUM ENZYMATIC ASSAY KIT by General Atomics — Product Code JII

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2003
Date Received
October 21, 2003
Clearance Type
Traditional
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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  • K042448 — DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT (October 29, 2004)

Other clearances for product code JII

  • K082001 — DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B (December 5, 2008)
  • K912244 — UROTEST GPH (November 22, 1991)