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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ammonium molybdate and ammonium vanadate, phospholipids
510(k) Number K905829
Device Name DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
Applicant
KAMIYA BIOMEDICAL CO.
P.O. BOX 6067
THOUSAND OAKS,  CA  91359
Applicant Contact MARY REES
Correspondent
KAMIYA BIOMEDICAL CO.
P.O. BOX 6067
THOUSAND OAKS,  CA  91359
Correspondent Contact MARY REES
Regulation Number862.1575
Classification Product Code
CEL  
Date Received12/31/1990
Decision Date 01/30/1991
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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