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FDA 510(k) Application Details - K971985
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
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510(K) Number
K971985
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
CRESTAT DIAGNOSTICS, INC.
374 GOODHILL RD.
WESTON, CT 06883 US
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Contact
MARY REES
Other 510(k) Applications for this Contact
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
05/29/1997
Decision Date
10/20/1997
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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