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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K911050
Device Name LH IRMA IMMUNOMAG
Applicant
Pantex, Div. Bio-Analysis, Inc.
1737 21st St.
Santa Monica,  CA  90404
Applicant Contact NEIL Y CHIAMORI
Correspondent
Pantex, Div. Bio-Analysis, Inc.
1737 21st St.
Santa Monica,  CA  90404
Correspondent Contact NEIL Y CHIAMORI
Regulation Number862.1485
Classification Product Code
CEP  
Date Received03/08/1991
Decision Date 04/12/1991
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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