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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K812777
Device Name DIRECT IRON REAGENT SET
Applicant
The Dow Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Dow Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1410
Classification Product Code
JIY  
Date Received10/05/1981
Decision Date 10/19/1981
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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