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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 K964756
Device Name PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
Applicant
Wano-Tech Corp.
260 Harbor Blvd.
Belmont,  CA  94002
Applicant Contact K. PETER MOSSNER
Correspondent
Wano-Tech Corp.
260 Harbor Blvd.
Belmont,  CA  94002
Correspondent Contact K. PETER MOSSNER
Regulation Number862.1020
Classification Product Code
JFH  
Date Received11/27/1996
Decision Date 04/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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