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510(k) K110616

THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO by Microgenics Corp. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2011
Date Received
March 3, 2011
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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  • K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (April 8, 2011)
  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)
  • K101745 — THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY (April 8, 2011)

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