Device Classification Name |
dna-reagents, mycobacterium spp.
|
510(k) Number |
K871795 |
Device Name |
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. |
Applicant |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
BRUNI, PH.D. |
Correspondent |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
BRUNI, PH.D. |
Regulation Number | 866.3370
|
Classification Product Code |
|
Date Received | 05/07/1987 |
Decision Date | 07/30/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|