FDA 510(k) Application Details - K083430

Device Classification Name	Internal Polymerase Chain Reaction Control, Not Assay Specific   More FDA Info for this Device
510(K) Number	K083430
Device Name	Internal Polymerase Chain Reaction Control, Not Assay Specific
Applicant	NANOGEN, INC. 10398 PACIFIC CENTER CT. SAN DIEGO, CA 92121-4340 US Other 510(k) Applications for this Company
Contact	E. JOSEPH MCMULLEN Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	OLD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2008
Decision Date	01/15/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review