Device Classification Name |
Dna-Reagents, Neisseria
|
510(k) Number |
K920301 |
Device Name |
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY |
Applicant |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
RUBEN CHAIREZ |
Correspondent |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
RUBEN CHAIREZ |
Regulation Number | 866.3390
|
Classification Product Code |
|
Date Received | 01/21/1992 |
Decision Date | 04/26/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|