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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Human Placental Lactogen
510(k) Number K782099
Device Name RIA TEST, NORDICALB HPL
Applicant
Nordiclab Intl.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Nordiclab Intl.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1585
Classification Product Code
JMF  
Date Received12/18/1978
Decision Date 01/10/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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