Device Classification Name |
Herpes Simplex Virus Nucleic Acid Amplification Assay
|
510(k) Number |
K140198 |
Device Name |
IMDX HSV-1/2 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 | 866.3305
|
Classification Product Code |
|
Date Received | 01/27/2014 |
Decision Date | 05/13/2014 |
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
|
|
|