Device Classification Name |
C. Difficile Toxin Gene Amplification Assay
|
510(k) Number |
K132235 |
Device Name |
IMDX C.DIFFICILE FOR ABBOTT M2000 |
Applicant |
Intelligent Medical Devices, Inc. |
180 CABOT ST |
BEVERLY,
MA
01915
|
|
Applicant Contact |
FRAN WHITE |
Correspondent |
Intelligent Medical Devices, Inc. |
180 CABOT ST |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
FRAN WHITE |
Regulation Number | 866.3130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/18/2013 |
Decision Date | 10/11/2013 |
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
|
|
|