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510(k) K132174

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

K132174 is an FDA 510(k) premarket notification submitted by Techno-Path Manufacturing , Ltd. for the device "MULTICHEM WBT". The FDA issued a decision of Substantially Equivalent on September 20, 2013. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Techno-Path Manufacturing , Ltd. has at least 6 other 510(k) clearances on record.

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.

  • K242492 — Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); (December 30, 2025)
  • 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)

Other clearances for product code DIF

  • K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, (February 23, 2016)
  • K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/N (December 16, 2013)
  • K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (July 3, 2012)
  • K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (May 18, 2012)
  • K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOG (March 27, 2012)
  • K103656 — THERMO SCIENTIFIC MAS R DOA TOTAL (March 24, 2011)
  • 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)

FDA data resources