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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 K901673
Device Name PROLACTIN (LACTOGEN) TEST SYSTEM
Applicant
Baxter Healthcare Corp
P.O.Box 520672
Miami,  FL  33152
Applicant Contact A HORNBAKER
Correspondent
Baxter Healthcare Corp
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact A HORNBAKER
Regulation Number862.1625
Classification Product Code
CFT  
Date Received04/10/1990
Decision Date 06/12/1990
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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