Device Classification Name |
Dna-Reagents, Mycobacterium Spp.
|
510(k) Number |
K900202 |
Device Name |
SNAP MYCOBACTERIA AVIUM COMPLEX |
Applicant |
SYNGENE, INC. |
10030 BARNES CANYON RD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
PHILIP M FANTASIA |
Correspondent |
SYNGENE, INC. |
10030 BARNES CANYON RD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
PHILIP M FANTASIA |
Regulation Number | 866.3370
|
Classification Product Code |
|
Date Received | 01/16/1990 |
Decision Date | 04/03/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|