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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 K030015
Device Name ATAC PAK PHOSPHORUS REAGENT
Applicant
ELAN DIAGNOSTICS
1075 W. LAMBERT RD., SUITE D
BREA,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
ELAN DIAGNOSTICS
1075 W. LAMBERT RD., SUITE D
BREA,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1580
Classification Product Code
CEO  
Date Received01/02/2003
Decision Date 03/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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