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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 K953657
Device Name ABBOTT AXSYM PROLACTIN(MODIFICATION)
Applicant
Abbott Mfg., Inc.
200 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact JOY C SONSALLA
Correspondent
Abbott Mfg., Inc.
200 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact JOY C SONSALLA
Regulation Number862.1625
Classification Product Code
CFT  
Subsequent Product Codes
JIS   JJX  
Date Received07/18/1995
Decision Date 09/25/1995
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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