Device Classification Name |
gastrointestinal pathogen panel multiplex nucleic acid-based assay system
|
510(k) Number |
K143648 |
Device Name |
BD MAX Enteric Parasite Panel, BD MAX Instrument |
Applicant |
BECTON, DICKINSON AND COMPANY |
7 LOVETON CIR. |
SPARKS,
MD
21152
|
|
Applicant Contact |
PAUL SWIFT |
Correspondent |
BECTON, DICKINSON AND COMPANY |
7 LOVETON CIR. |
SPARKS,
MD
21152
|
|
Correspondent Contact |
PAUL SWIFT |
Regulation Number | 866.3990
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/22/2014 |
Decision Date | 08/25/2015 |
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
|
|
|