Device Classification Name |
dna probe, yeast
|
510(k) Number |
K931151 |
Device Name |
AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA |
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 | 03/08/1993 |
Decision Date | 06/18/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|