Device Classification Name |
Dna-Reagents, Chlamydia
|
510(k) Number |
K010891 |
Device Name |
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 |
Applicant |
DIGENE CORP. |
1201 CLOPPER RD. |
GAITHERSBURG,
MD
20878
|
|
Applicant Contact |
MARK A DEL VECCHIO |
Correspondent |
DIGENE CORP. |
1201 CLOPPER RD. |
GAITHERSBURG,
MD
20878
|
|
Correspondent Contact |
MARK A DEL VECCHIO |
Regulation Number | 866.3120
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/26/2001 |
Decision Date | 09/25/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|