Device Classification Name |
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
|
510(k) Number |
K181427 |
Device Name |
BD MAX Enteric Viral Panel, BD MAX Instrument |
Applicant |
Becton, Dickinson and Company |
7 Loveton Circle |
Sparks,
MD
21152
|
|
Applicant Contact |
Laura Stewart |
Correspondent |
Becton, Dickinson and Company |
7 Loveton Circle |
Sparks,
MD
21152
|
|
Correspondent Contact |
Laura Stewart |
Regulation Number | 866.3990
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/01/2018 |
Decision Date | 11/29/2018 |
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
|
|
|