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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 K895094
Device Name TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
Applicant
HYBRITECH, INC.
11095 TORREYANA RD.
P.O. BOX 269006
SAN DIEGO,  CA  92126
Applicant Contact JOANNE MARTINIS
Correspondent
HYBRITECH, INC.
11095 TORREYANA RD.
P.O. BOX 269006
SAN DIEGO,  CA  92126
Correspondent Contact JOANNE MARTINIS
Regulation Number862.1485
Classification Product Code
CEP  
Date Received08/14/1989
Decision Date 10/31/1989
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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