Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
|
510(k) Number |
K102740 |
Device Name |
NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 |
Applicant |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Applicant Contact |
JOCELYN JENNINGS |
Correspondent |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Correspondent Contact |
JOCELYN JENNINGS |
Regulation Number | 866.1640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/22/2010 |
Decision Date | 05/20/2011 |
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
|
|
|