Device Classification Name |
dna-reagents, neisseria
|
510(k) Number |
K981485 |
Device Name |
HYBRID CAPTURE II GC-ID |
Applicant |
DIGENE CORP. |
9000 VIRGINIA MANOR RD., |
BELTSVILLE,
MD
20705
|
|
Applicant Contact |
MARK A DEL VECCHIO |
Correspondent |
DIGENE CORP. |
9000 VIRGINIA MANOR RD., |
BELTSVILLE,
MD
20705
|
|
Correspondent Contact |
MARK A DEL VECCHIO |
Regulation Number | 866.3390
|
Classification Product Code |
|
Date Received | 04/24/1998 |
Decision Date | 11/29/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|