Device Classification Name |
dna-reagents, mycobacterium spp.
|
510(k) Number |
K862614 |
Device Name |
RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX |
Applicant |
GEN-PROBE, INC. |
9620 CHESAPEAKE DR. |
SAN DIEGO,
CA
92123
|
|
Applicant Contact |
ADAMS, PHD |
Correspondent |
GEN-PROBE, INC. |
9620 CHESAPEAKE DR. |
SAN DIEGO,
CA
92123
|
|
Correspondent Contact |
ADAMS, PHD |
Regulation Number | 866.3370
|
Classification Product Code |
|
Date Received | 07/09/1986 |
Decision Date | 11/10/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|