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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 K874153
Device Name EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number862.1580
Classification Product Code
CEO  
Date Received10/13/1987
Decision Date 11/04/1987
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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