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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 K994419
Device Name FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
Applicant
QUALISYS DIAGNOSTICS, INC.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92009
Applicant Contact VIJAY K MAHANT
Correspondent
QUALISYS DIAGNOSTICS, INC.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92009
Correspondent Contact VIJAY K MAHANT
Regulation Number866.6010
Classification Product Code
LTJ  
Subsequent Product Code
JJQ  
Date Received12/29/1999
Decision Date 06/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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