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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
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