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510(k) K081478

RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS by Bionostics, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2008
Date Received
May 27, 2008
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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  • K091914 — OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION (November 6, 2009)
  • K082395 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MOD (September 18, 2008)

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