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510(k) K063754

DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 by Dade Behring, Inc. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2007
Date Received
December 19, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
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  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

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