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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
510(k) Number K894288
Device Name PHOSPHORUS TEST ITEM NUMBER 65416
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Applicant Contact ANNA BENTLEY
Correspondent
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Correspondent Contact ANNA BENTLEY
Regulation Number862.1520
Classification Product Code
CED  
Date Received06/23/1989
Decision Date 08/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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