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FDA 510(k) Application Details - K992502
Device Classification Name
Test,Carbohydrate Deficient Transferrin
More FDA Info for this Device
510(K) Number
K992502
Device Name
Test,Carbohydrate Deficient Transferrin
Applicant
AXIS
PO BOX 262069
SAN DIEGO, CA 92196 US
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Contact
RONALD G LEONARDI
Other 510(k) Applications for this Contact
Regulation Number
862.1360
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Classification Product Code
NAO
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More FDA Info for this Product Code
Date Received
07/26/1999
Decision Date
12/21/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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