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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 K871008
Device Name MICROMEDIC NEONATAL T4 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 Received03/13/1987
Decision Date 05/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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