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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 K820039
Device Name LEECO PRL-QUANT DIAGNOSTIC TEST KIT
Applicant
LEECO DIAGNOSTICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
LEECO DIAGNOSTICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1625
Classification Product Code
CFT  
Date Received01/07/1982
Decision Date 01/22/1982
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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