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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
510(k) Number K891218
Device Name IQ/QCA PHOSPHORUS
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact J ARNSBERGER
Regulation Number862.1580
Classification Product Code
CEO  
Date Received03/07/1989
Decision Date 03/22/1989
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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