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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 K981769
Device Name HICHEM PHOSPHORUS REAGENT KIT
Applicant
Elan Pharma, Inc.
231 N. Puente St.
Brea,  CA  92621
Applicant Contact WYNN STOCKING
Correspondent
Elan Pharma, Inc.
231 N. Puente St.
Brea,  CA  92621
Correspondent Contact WYNN STOCKING
Regulation Number862.1580
Classification Product Code
CEO  
Subsequent Product Code
JIS  
Date Received05/19/1998
Decision Date 06/29/1998
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
Predetermined Change
Control Plan Authorized		 No
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