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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Culture, Chromosome
510(k) Number K790239
Device Name PHYTOHAEMAGGLUTININ
Applicant
Pharmacia Fine Chemicals
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pharmacia Fine Chemicals
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.2260
Classification Product Code
KIQ  
Date Received02/01/1979
Decision Date 03/08/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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