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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 K895999
Device Name PHOSPHORUS
Applicant
AMERICAN MONITOR CORP.
P.O. BOX 68505
INDIANAPOLIS,  IN  46268
Applicant Contact JENNIFER LINE
Correspondent
AMERICAN MONITOR CORP.
P.O. BOX 68505
INDIANAPOLIS,  IN  46268
Correspondent Contact JENNIFER LINE
Regulation Number862.1580
Classification Product Code
CEO  
Date Received10/13/1989
Decision Date 01/11/1990
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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