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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 K893508
Device Name PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
Applicant
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact J NORWOOD
Correspondent
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact J NORWOOD
Regulation Number862.1020
Classification Product Code
JFH  
Date Received05/05/1989
Decision Date 08/04/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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