Device Classification Name |
enzyme linked immunoabsorbent assay, rubeola igm
|
510(k) Number |
K140455 |
Device Name |
CAPTIA MEASLES IGM |
Applicant |
TRINITY BIOTECH USA |
2823 Girts Rd |
JAMESTOWN,
NY
14701
|
|
Applicant Contact |
Bonnie B DeJoy |
Correspondent |
TRINITY BIOTECH USA |
2823 Girts Rd |
JAMESTOWN,
NY
14701
|
|
Correspondent Contact |
Bonnie B DeJoy |
Regulation Number | 866.3520
|
Classification Product Code |
|
Date Received | 02/24/2014 |
Decision Date | 05/22/2014 |
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
|
Recalls |
CDRH Recalls
|
|
|