Device Classification Name |
Dna Probe, Gardnerella Vaginalis
|
510(k) Number |
K923133 |
Device Name |
AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS |
Applicant |
MICROPROBE CORP. |
1725 220TH STREET, S.E., 104 |
BOTHELL,
WA
98021
|
|
Applicant Contact |
RUSSEL K ENNS |
Correspondent |
MICROPROBE CORP. |
1725 220TH STREET, S.E., 104 |
BOTHELL,
WA
98021
|
|
Correspondent Contact |
RUSSEL K ENNS |
Regulation Number | 866.2660
|
Classification Product Code |
|
Date Received | 06/29/1992 |
Decision Date | 09/25/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|