Device Classification Name |
dna-reagents, neisseria
|
510(k) Number |
K991268 |
Device Name |
GONOSTAT GONOCOCCAL DETECTION KIT |
Applicant |
SIERRA DIAGNOSTICS |
1900 K STREET, N.W. |
WASHINGTON,
DC
20006 -1108
|
|
Applicant Contact |
DONALD R STONE |
Correspondent |
SIERRA DIAGNOSTICS |
1900 K STREET, N.W. |
WASHINGTON,
DC
20006 -1108
|
|
Correspondent Contact |
DONALD R STONE |
Regulation Number | 866.3390
|
Classification Product Code |
|
Date Received | 04/13/1999 |
Decision Date | 08/11/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|