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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 K940549
Device Name ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
Applicant
BIO-RAD LABORATORIES, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Applicant Contact DENNIS S GRIFFIN
Correspondent
BIO-RAD LABORATORIES, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Correspondent Contact DENNIS S GRIFFIN
Regulation Number862.1485
Classification Product Code
CEP  
Date Received02/07/1994
Decision Date 04/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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