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FDA 510(k) Application Details - K962489
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
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510(K) Number
K962489
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
6025 NICOLLE ST.
VENTURA, CA 93003 US
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Contact
MICHAEL D BICK
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Regulation Number
864.7290
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Classification Product Code
GGP
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More FDA Info for this Product Code
Date Received
06/26/1996
Decision Date
07/31/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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