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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 K884748
Device Name TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact LEONARD A DWARICA
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact LEONARD A DWARICA
Regulation Number862.1020
Classification Product Code
JFH  
Date Received11/14/1988
Decision Date 01/30/1989
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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