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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 K780148
Device Name RIA FOR FOLATES & VIT. B12, COMBO KIT
Applicant
Ria Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ria Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1295
Classification Product Code
CGN  
Date Received01/30/1978
Decision Date 03/03/1978
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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