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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K913162
Device Name ENZYMUN-TEST ESTRADIOL
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact JOHN D STEVENS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact JOHN D STEVENS
Regulation Number862.1260
Classification Product Code
CHP  
Date Received07/17/1991
Decision Date 09/27/1991
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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