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510(k) K131479

V8 SP NORMAL CONTROL, ABNORMAL CONTROL by Helena Laboratories — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2013
Date Received
May 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
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