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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K880344
Device Name IQ ALKALINE PHOSPHATASE
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Correspondent Contact J ARNSBERGER
Regulation Number862.1050
Classification Product Code
CJK  
Date Received01/26/1988
Decision Date 03/01/1988
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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