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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 K871321
Device Name FLOW-PAC INORGANIC PHOSPHORUS REAGENTS
Applicant
AMERICAN RESEARCH PRODUCTS CO.
30175 SOLON INDUSTRIAL PKWY.
P.O. BOX 39098
SOLON,  OH  44139
Applicant Contact J. A LEVEY
Correspondent
AMERICAN RESEARCH PRODUCTS CO.
30175 SOLON INDUSTRIAL PKWY.
P.O. BOX 39098
SOLON,  OH  44139
Correspondent Contact J. A LEVEY
Regulation Number862.1580
Classification Product Code
CEO  
Date Received04/03/1987
Decision Date 04/22/1987
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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