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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Progesterone
510(k) Number K811369
Device Name NATAL-TEC PROGESTERONE
Applicant
Armkel, LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Armkel, LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1620
Classification Product Code
JLS  
Date Received05/14/1981
Decision Date 05/29/1981
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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