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FDA 510(k) Application Details - K952126
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
More FDA Info for this Device
510(K) Number
K952126
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
AALTO SCIENTIFIC LTD.
1160 JOSHUA WAY
VISTA, CA 92083-7836 US
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Contact
KEVIN JONES
Other 510(k) Applications for this Contact
Regulation Number
864.7290
More FDA Info for this Regulation Number
Classification Product Code
GGP
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More FDA Info for this Product Code
Date Received
05/08/1995
Decision Date
02/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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