FDA 510(k) Application Details - K090330

Device Classification Name Enzymatic Method, Creatinine

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510(K) Number K090330
Device Name Enzymatic Method, Creatinine
Applicant Siemens Healthcare Diagnostics Inc.
PO BOX 6101
MS 514
NEWARK, DE 19714-6101 US
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Contact ROSE T MARINELLI
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Regulation Number 862.1225

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Classification Product Code JFY
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Date Received 02/10/2009
Decision Date 05/22/2009
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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