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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K941168
Device Name CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
Applicant
Incstar Corp.
1990 Industrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact MARY E BEST
Correspondent
Incstar Corp.
1990 Industrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact MARY E BEST
Regulation Number862.1260
Classification Product Code
CHP  
Date Received03/14/1994
Decision Date 09/07/1994
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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