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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
510(k) Number K910672
Device Name J&S PEDIATRIC IRON SATURATING REAGENT
Applicant
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Applicant Contact MARSHALL E DEUTSCH
Correspondent
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Correspondent Contact MARSHALL E DEUTSCH
Regulation Number862.1415
Classification Product Code
JQE  
Date Received02/15/1991
Decision Date 04/29/1991
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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