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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850140
Device Name CORNING MAGIC 1-FREE T3 RADIOIMMUNOASSAY
Applicant
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Applicant Contact William J Pignato
Correspondent
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Correspondent Contact William J Pignato
Date Received01/14/1985
Decision Date 02/06/1985
Decision Substantially Equivalent (SESE)
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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