The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Flu, Genexpert Dx Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 And 4.0.
Device ID | K103766 |
510k Number | K103766 |
Device Name: | XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 |
Classification | 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
Contact | Kerry J Flom |
Correspondent | Kerry J Flom CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
Product Code | OQW |
Subsequent Product Code | OCC |
Subsequent Product Code | OOI |
CFR Regulation Number | 866.3332 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-23 |
Decision Date | 2011-04-21 |
Summary: | summary |