Device Classification Name |
Dna Probe, Nucleic Acid Amplification, Chlamydia
|
510(k) Number |
K973718 |
Device Name |
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
Applicant |
ROCHE MOLECULAR SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 |
BRANCHBURG,
NJ
08876
|
|
Applicant Contact |
ALEX WESOLOWSKI |
Correspondent |
ROCHE MOLECULAR SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 |
BRANCHBURG,
NJ
08876
|
|
Correspondent Contact |
ALEX WESOLOWSKI |
Regulation Number | 866.3120
|
Classification Product Code |
|
Date Received | 09/29/1997 |
Decision Date | 12/15/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|