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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K132091
Device Name MULTICHEM IA AND IA PLUS
Applicant
TECHNO-PATH MANUFACTURING LTD.
325 BIG ELM ST.
HIGHLAND VILLAGE,  TX  75077
Applicant Contact STEPHANIE G GARTH
Correspondent
TECHNO-PATH MANUFACTURING LTD.
325 BIG ELM ST.
HIGHLAND VILLAGE,  TX  75077
Correspondent Contact STEPHANIE G GARTH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/08/2013
Decision Date 09/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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