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FDA 510(k) Application Details - K030873
Device Classification Name
Enzymatic Method, Ammonia
More FDA Info for this Device
510(K) Number
K030873
Device Name
Enzymatic Method, Ammonia
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY GB
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Contact
LYNNE HAMILTON
Other 510(k) Applications for this Contact
Regulation Number
862.1065
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Classification Product Code
JIF
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More FDA Info for this Product Code
Date Received
03/20/2003
Decision Date
05/12/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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