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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 K790580
Device Name RIA KIT, PROSTATIC ACID
Applicant
Monitor Science Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Monitor Science Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1020
Classification Product Code
JFH  
Date Received03/27/1979
Decision Date 05/25/1979
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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