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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K001603
Device Name REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
Applicant
Repromedix Corp.
86 Cummings Park,
Woburn,  MA  01801
Applicant Contact HAN-SOO KIM
Correspondent
Repromedix Corp.
86 Cummings Park,
Woburn,  MA  01801
Correspondent Contact HAN-SOO KIM
Regulation Number862.1700
Classification Product Code
KLI  
Date Received05/24/2000
Decision Date 10/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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