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510(k) K132174

MULTICHEM WBT by Techno-Path Manufacturing , Ltd. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2013
Date Received
July 15, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Techno-Path Manufacturing , Ltd.

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  • K162530 — Multichem IA Plus (March 31, 2017)
  • K132751 — MULTICHEM S PLUS / S PLUS (ASSAYED) (October 22, 2013)
  • K131993 — MULTICHEM U (October 15, 2013)
  • K131992 — MULTICHEM P (September 25, 2013)
  • K132091 — MULTICHEM IA AND IA PLUS (September 20, 2013)

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  • K093577 — LIQUICHEK OPIATE CONTROL (March 12, 2010)
  • K080085 — MAS TOX CONTROL (April 30, 2008)
  • K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMI (March 25, 2008)
  • K072721 — LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC (December 11, 2007)