Device Classification Name |
dna-reagents, neisseria
|
510(k) Number |
K940979 |
Device Name |
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR |
Applicant |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
DAVID E DUNN |
Correspondent |
GEN-PROBE, INC. |
9880 CAMPUS POINT DR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
DAVID E DUNN |
Regulation Number | 866.3390
|
Classification Product Code |
|
Date Received | 03/01/1994 |
Decision Date | 10/31/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|