FDA 510(k) Application Details - K112142

Device Classification Name	Assay, Porphyrin, Spectrophotometry, Lithium   More FDA Info for this Device
510(K) Number	K112142
Device Name	Assay, Porphyrin, Spectrophotometry, Lithium
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	ROSE T MARINELLI Other 510(k) Applications for this Contact
Regulation Number	862.3560   More FDA Info for this Regulation Number
Classification Product Code	NDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2011
Decision Date	11/04/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review