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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prostate-specific antigen (psa) for management of prostate cancers
510(k) Number K990234
Device Name QUALISYS PSA IMMUNOASSAY
Applicant
QUALISYS DIAGNOSTICS, INC.
16 TECHNOLOGY DR., SUITE 118
IRVINE,  CA  92618
Applicant Contact GRACE KWAN
Correspondent
QUALISYS DIAGNOSTICS, INC.
16 TECHNOLOGY DR., SUITE 118
IRVINE,  CA  92618
Correspondent Contact GRACE KWAN
Regulation Number866.6010
Classification Product Code
LTJ  
Date Received01/25/1999
Decision Date 07/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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