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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Thyroxine
510(k) Number K861320
Device Name MMS T4 RIA KIT
Applicant
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Applicant Contact DEBORAH L LINDEMUTH
Correspondent
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact DEBORAH L LINDEMUTH
Regulation Number862.1700
Classification Product Code
CDX  
Date Received04/08/1986
Decision Date 04/24/1986
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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