Device Classification Name |
Analyzer, Chemistry, Micro, For Clinical Use
|
510(k) Number |
K012966 |
Device Name |
ROCHE COBAS TAQMAN ANALYZER |
Applicant |
ROCHE MOLECULAR SYSTEMS, INC. |
4300 HACIENDA DR. |
PLEASANTON,
CA
94588 -2722
|
|
Applicant Contact |
GARY S RIORDAN |
Correspondent |
ROCHE MOLECULAR SYSTEMS, INC. |
4300 HACIENDA DR. |
PLEASANTON,
CA
94588 -2722
|
|
Correspondent Contact |
GARY S RIORDAN |
Regulation Number | 862.2170
|
Classification Product Code |
|
Date Received | 09/04/2001 |
Decision Date | 02/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|