MULTICHEM IA AND IA PLUS

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 Ia And Ia Plus.

Pre-market Notification Details

Device IDK132091
510k NumberK132091
Device Name:MULTICHEM IA AND IA PLUS
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 Received2013-07-08
Decision Date2013-09-20
Summary:summary

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