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FDA 510(k) Application Details - K050178
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K050178
Device Name
Assay, Glycosylated Hemoglobin
Applicant
GENERAL ATOMICS
3550 GENERAL ATOMICS COURT
SAN DIEGO, CA 92121 US
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Contact
HUAN TRAN
Other 510(k) Applications for this Contact
Regulation Number
864.7470
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Classification Product Code
LCP
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More FDA Info for this Product Code
Date Received
01/26/2005
Decision Date
06/28/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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