Device Classification Name |
cryptosporidium spp.
|
510(k) Number |
K121565 |
Device Name |
UNI-GOLD CRYPTOSPORIDIUM |
Applicant |
TRINITY BIOTECH |
5919 FARNSWORTH CT. |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
LUPE KAGAN |
Correspondent |
TRINITY BIOTECH |
5919 FARNSWORTH CT. |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
LUPE KAGAN |
Regulation Number | 866.3220
|
Classification Product Code |
|
Date Received | 05/29/2012 |
Decision Date | 02/08/2013 |
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
|
|
|