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510(k) K060359

ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 by Denka Seiken Co., Ltd. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2006
Date Received
February 13, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
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  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
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