Device Classification Name |
dna-reagents, neisseria
|
510(k) Number |
K974342 |
Device Name |
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
Applicant |
ROCHE MOLECULAR SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 |
SOMERVILLE,
NJ
08876 -3711
|
|
Applicant Contact |
ALEX WESOLOWSKI |
Correspondent |
ROCHE MOLECULAR SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 |
SOMERVILLE,
NJ
08876 -3711
|
|
Correspondent Contact |
ALEX WESOLOWSKI |
Regulation Number | 866.3390
|
Classification Product Code |
|
Date Received | 11/18/1997 |
Decision Date | 05/28/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|