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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 K931228
Device Name PROGESTERONE RADIOIMMUNOASSAY KIT
Applicant
IMMUNOTECH CORP.
130, AVENUE JEAN DE LATTRE DE
TASSIGNY-BP 177, 13276 MARSEIL
CEDEX 9 (FRANCE),  FR
Applicant Contact PRINCE
Correspondent
IMMUNOTECH CORP.
130, AVENUE JEAN DE LATTRE DE
TASSIGNY-BP 177, 13276 MARSEIL
CEDEX 9 (FRANCE),  FR
Correspondent Contact PRINCE
Regulation Number862.1620
Classification Product Code
JLS  
Date Received03/10/1993
Decision Date 10/22/1993
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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