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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferrozine (Colorimetric) Iron Binding Capacity
510(k) Number K893662
Device Name J&S IRON SATURATING REAGENTS
Applicant
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Applicant Contact MARSHALL DEUTSCH
Correspondent
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Correspondent Contact MARSHALL DEUTSCH
Regulation Number862.1415
Classification Product Code
JMO  
Date Received05/15/1989
Decision Date 07/20/1989
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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