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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, Thymolphthale Inmonophosphate
510(k) Number K800693
Device Name STANBIO PROSTATIC ACID PHOSPHATASE TEST
Applicant
Stanbio Laboratory
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Stanbio Laboratory
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1020
Classification Product Code
CKE  
Date Received03/27/1980
Decision Date 04/16/1980
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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