FDA 510(k) Application Details - K081103

Device Classification Name Calibrator, Multi-Analyte Mixture

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510(K) Number K081103
Device Name Calibrator, Multi-Analyte Mixture
Applicant Siemens Healthcare Diagnostics Inc.
PO BOX 6101
MAILBOX 514
NEWARK, DE 19714-6101 US
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Contact YUK-TING LEWIS
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Regulation Number 862.1150

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Classification Product Code JIX
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Date Received 04/18/2008
Decision Date 05/23/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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