Device Classification Name |
Real Time Nucleic Acid Amplification System
|
510(k) Number |
K093383 |
Device Name |
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG |
Applicant |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Applicant Contact |
MARIA OYASKI |
Correspondent |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Correspondent Contact |
MARIA OYASKI |
Regulation Number | 862.2570
|
Classification Product Code |
|
Date Received | 10/30/2009 |
Decision Date | 07/06/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|