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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase (Prostatic), Tartrate Inhibited
510(k) Number K844968
Device Name EPICHROME PAP
Applicant
Cetus Corp.
1400 Fifty-Third St.
Emeryville,  CA  94608
Applicant Contact WANDA DEVLAMINCK
Correspondent
Cetus Corp.
1400 Fifty-Third St.
Emeryville,  CA  94608
Correspondent Contact WANDA DEVLAMINCK
Regulation Number862.1020
Classification Product Code
JFH  
Date Received12/24/1984
Decision Date 02/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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