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FDA 510(k) Application Details - K983704
Device Classification Name
Control, Hemoglobin, Abnormal
More FDA Info for this Device
510(K) Number
K983704
Device Name
Control, Hemoglobin, Abnormal
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE, NJ 08876-3771 US
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Contact
RITA SMITH
Other 510(k) Applications for this Contact
Regulation Number
864.7415
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Classification Product Code
JCM
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More FDA Info for this Product Code
Date Received
10/21/1998
Decision Date
02/10/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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