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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diazo colorimetry, bilirubin
510(k) Number K860257
Device Name DIRECT BILIRUBIN
Applicant
POINTE SCIENTIFIC, INC.
P.O. BOX 8569
DETROIT,  MI  48224
Applicant Contact JANUSZ M SZYSZKO
Correspondent
POINTE SCIENTIFIC, INC.
P.O. BOX 8569
DETROIT,  MI  48224
Correspondent Contact JANUSZ M SZYSZKO
Regulation Number862.1110
Classification Product Code
CIG  
Date Received01/24/1986
Decision Date 02/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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