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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 K131992
Device Name MULTICHEM P
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 Received06/28/2013
Decision Date 09/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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