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510(k) K063852

ACCESSA CHOLESTEROL PANEL by Home Access Health Corp. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2007
Date Received
December 28, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Home Access Health Corp.

  • K141944 — HOME ACCESS AIC TEST (March 13, 2015)

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