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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 K864882
Device Name FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
Applicant
POINTE SCIENTIFIC, INC.
P.O. BOX 8569
DETROIT,  MI  48224
Applicant Contact WILLIAM F WALTERS
Correspondent
POINTE SCIENTIFIC, INC.
P.O. BOX 8569
DETROIT,  MI  48224
Correspondent Contact WILLIAM F WALTERS
Regulation Number862.1410
Classification Product Code
JIY  
Date Received12/12/1986
Decision Date 01/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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