Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
|
510(k) Number |
K190771 |
Device Name |
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
Applicant |
Cepheid |
904 Caribbean Drive |
Sunnyvale,
CA
94089
|
|
Applicant Contact |
Yi-Ping Lin |
Correspondent |
Cepheid |
904 Caribbean Drive |
Sunnyvale,
CA
94089
|
|
Correspondent Contact |
Sudhakar Marla |
Regulation Number | 866.1640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/26/2019 |
Decision Date | 04/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|