Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
|
510(k) Number |
K142721 |
Device Name |
cobas MRSA/SA Test |
Applicant |
ROCHE MOLECULAR SYSTEMS, INC. |
4300 HACIENDA DRIVE |
PLEASANTON,
CA
94588 -2722
|
|
Applicant Contact |
Wilk von Gustedt |
Correspondent |
ROCHE MOLECULAR SYSTEMS, INC. |
4300 HACIENDA DRIVE |
PLEASANTON,
CA
94588 -2722
|
|
Correspondent Contact |
Wilk von Gustedt |
Regulation Number | 866.1640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/23/2014 |
Decision Date | 12/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|