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FDA 510(k) Application Details - K952337
Device Classification Name
Assay, Glycosylated Hemoglobin
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510(K) Number
K952337
Device Name
Assay, Glycosylated Hemoglobin
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE, NJ 08876-3771 US
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Contact
CAROL L KRIEGER
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
05/19/1995
Decision Date
02/09/1996
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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