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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 K132751
Device Name MULTICHEM S PLUS / S PLUS (ASSAYED)
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 Received09/03/2013
Decision Date 10/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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