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510(k) K003327

ALBUMIN by Jas Diagnostics, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2000
Date Received
October 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

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  • 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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