Device Classification Name |
C. Difficile Toxin Gene Amplification Assay
|
510(k) Number |
K130470 |
Device Name |
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT |
Applicant |
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) |
2555 Boul. du Parc-Technologique |
Quebec,
CA
G1P 4S5
|
|
Applicant Contact |
PATRICIA DIONNE |
Correspondent |
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) |
2555 Boul. du Parc-Technologique |
Quebec,
CA
G1P 4S5
|
|
Correspondent Contact |
PATRICIA DIONNE |
Regulation Number | 866.3130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/25/2013 |
Decision Date | 04/02/2013 |
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
|
|
|