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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
510(k) Number K812081
Device Name WAKO NEFA C TEST
Applicant
Wako Chemicals USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Wako Chemicals USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1290
Classification Product Code
JLG  
Date Received07/22/1981
Decision Date 08/12/1981
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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