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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 K885041
Device Name BIOTROL INORGANIC PHOSPHORUS
Applicant
Biotrol, USA, Inc.
113 Branywine Pkwy.
Westchester,  PA  19380
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
113 Branywine Pkwy.
Westchester,  PA  19380
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1580
Classification Product Code
CEO  
Date Received12/05/1988
Decision Date 01/30/1989
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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