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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 K790919
Device Name HPL RIA KIT
Applicant
TECHNIA DIAGNOSTICS LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TECHNIA DIAGNOSTICS LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1585
Classification Product Code
JMF  
Date Received05/14/1979
Decision Date 06/28/1979
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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