Device Classification Name |
test, natriuretic peptide
|
510(k) Number |
K073091 |
Device Name |
VIDAS NT-PROBNP ASSAY, MODEL: 30 449 |
Applicant |
BIOMERIEUX, INC. |
595 ANGLUM RD. |
HAZELWOOD,
MO
63042
|
|
Applicant Contact |
NIKITA S MAPP |
Correspondent |
BIOMERIEUX, INC. |
595 ANGLUM RD. |
HAZELWOOD,
MO
63042
|
|
Correspondent Contact |
NIKITA S MAPP |
Regulation Number | 862.1117
|
Classification Product Code |
|
Date Received | 11/01/2007 |
Decision Date | 02/29/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|