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FDA 510(k) Application Details - K061793
Device Classification Name
Photometric Method, Iron (Non-Heme)
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510(K) Number
K061793
Device Name
Photometric Method, Iron (Non-Heme)
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 MS 514
NEWARK, DE 19714-6101 US
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Contact
ANDREA M TASKER
Other 510(k) Applications for this Contact
Regulation Number
862.1410
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Classification Product Code
JIY
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More FDA Info for this Product Code
Date Received
06/26/2006
Decision Date
08/07/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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