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510(k) K051074

MAS IMMUNOSUPPRESSANT CONTROLS by Microgenics Corp. — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2005
Date Received
April 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)

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  • K040411 — DRI OXYCODONE ASSAY (May 27, 2004)
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  • K030616 — CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (March 31, 2003)
  • K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (July 14, 1999)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K971210 — SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (April 17, 1997)
  • K946119 — ROCHE-TDM ONLEIN(TM) CONTROLS (February 7, 1995)