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510(k) K103744

DROPPER A1C DIABETES CONTROL by Quantimetrix Corp. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2011
Date Received
December 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K013662 — MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (March 8, 2002)
  • K010337 — LIPOPRINT SYSTEM, LDL SUBFRACTIONS (July 25, 2001)

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