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510(k) K141944

HOME ACCESS AIC TEST by Home Access Health Corp. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2015
Date Received
July 17, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

Other clearances by Home Access Health Corp.

  • K063852 — ACCESSA CHOLESTEROL PANEL (November 9, 2007)

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