MULTICHEM U

Multi-analyte Controls, All Kinds (assayed)

TECHNO-PATH MANUFACTURING LTD.

The following data is part of a premarket notification filed by Techno-path Manufacturing Ltd. with the FDA for Multichem U.

Pre-market Notification Details

Device IDK131993
510k NumberK131993
Device Name:MULTICHEM U
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant TECHNO-PATH MANUFACTURING LTD. 325 BIG ELM ST. Highland Village,  TX  75077
ContactStephanie G Garth
CorrespondentStephanie G Garth
TECHNO-PATH MANUFACTURING LTD. 325 BIG ELM ST. Highland Village,  TX  75077
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-28
Decision Date2013-10-15
Summary:summary

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