Device Classification Name |
enzyme linked immunoabsorbent assay, (chlamydiae group)
|
510(k) Number |
K905787 |
Device Name |
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST |
Applicant |
VITEK SYSTEMS, INC. |
1022 HINGHAM ST. |
ROCKLAND,
MA
02370
|
|
Applicant Contact |
WINTERS HEARD |
Correspondent |
VITEK SYSTEMS, INC. |
1022 HINGHAM ST. |
ROCKLAND,
MA
02370
|
|
Correspondent Contact |
WINTERS HEARD |
Regulation Number | 866.3120
|
Classification Product Code |
|
Date Received | 12/27/1990 |
Decision Date | 04/29/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|