Device Classification Name |
Dna-Reagents, Mycobacterium Spp.
|
510(k) Number |
K864597 |
Device Name |
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA |
Applicant |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
DANIEL L KACIAN,PHD |
Correspondent |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
DANIEL L KACIAN,PHD |
Regulation Number | 866.3370
|
Classification Product Code |
|
Date Received | 11/24/1986 |
Decision Date | 04/20/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|