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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name O-Phthalaldehyde, Urea Nitrogen
510(k) Number K842772
Device Name PHARMACIA B2-MICRO RIA
Applicant
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Applicant Contact ALBERT P MAYO
Correspondent
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Correspondent Contact ALBERT P MAYO
Regulation Number862.1770
Classification Product Code
JGZ  
Date Received07/16/1984
Decision Date 11/01/1984
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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