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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K954332
Device Name RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA
Regulation Number862.1295
Classification Product Code
CGN  
Date Received09/18/1995
Decision Date 01/24/1996
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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