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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 K931361
Device Name IL TEST PHOSPHORUS
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
P.O. BOX 9113
LEXINGTON,  MA  02173
Applicant Contact WALLIS CADY
Correspondent
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
P.O. BOX 9113
LEXINGTON,  MA  02173
Correspondent Contact WALLIS CADY
Regulation Number862.1580
Classification Product Code
CEO  
Date Received03/17/1993
Decision Date 05/11/1993
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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