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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 K760406
Device Name CAFFEINE DILUENT
Applicant
J.T. BAKER CHEMICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
J.T. BAKER CHEMICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1110
Classification Product Code
CIG  
Date Received08/09/1976
Decision Date 10/29/1976
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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