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510(k) K242492

Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) by Techno-Path Manufacturing , Ltd. — Product Code QCH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2025
Date Received
August 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assayed Quality Control Material For Clinical Microbiology Assays
Device Class
Class II
Regulation Number
866.3920
Review Panel
MI
Submission Type

Serologic controls for microbiology assays

Other clearances by Techno-Path Manufacturing , Ltd.

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  • K132751 — MULTICHEM S PLUS / S PLUS (ASSAYED) (October 22, 2013)
  • K131993 — MULTICHEM U (October 15, 2013)
  • K131992 — MULTICHEM P (September 25, 2013)
  • K132174 — MULTICHEM WBT (September 20, 2013)
  • K132091 — MULTICHEM IA AND IA PLUS (September 20, 2013)