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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 K811757
Device Name NEIA PAP ENZYMEIMMUNOASSAY
Applicant
New England Immunology Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
New England Immunology Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1020
Classification Product Code
JFH  
Date Received06/22/1981
Decision Date 08/13/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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