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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K860823
Device Name ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
Applicant
Cis-Us, Inc.
1983 Marcus Ave.
Lake Success,  NY  11042
Applicant Contact MICHAEL D GARRETT
Correspondent
Cis-Us, Inc.
1983 Marcus Ave.
Lake Success,  NY  11042
Correspondent Contact MICHAEL D GARRETT
Regulation Number862.1625
Classification Product Code
CFT  
Date Received03/04/1986
Decision Date 08/19/1986
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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