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510(k) K011441

JAS CALCIUM (ARSENAZO) REAGENT by Jas Diagnostics, Inc. — Product Code CJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2001
Date Received
May 10, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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  • K022519 — LDL CHOLESTEROL (AUTOMATED) (September 30, 2002)
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  • K020454 — CHEMISTRY CALIBRATOR (April 8, 2002)
  • K020282 — JAS AMYLASE LIQUID REAGENT (February 28, 2002)
  • K013912 — CREATINE KINASE (CK-NAC) (January 18, 2002)
  • K013698 — AST (SGOT) (December 21, 2001)
  • K012332 — JAS CARBON DIOXIDE LIQUID REAGENT (September 6, 2001)

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