Device Classification Name |
Kit, Screening, Yeast
|
510(k) Number |
K891476 |
Device Name |
C. ALBICANS SCREEN |
Applicant |
CARR-SCARBOROUGH MICROBIOLOGICALS, INC. |
P.O. BOX 1328 |
STONE MOUNTAIN,
GA
30086
|
|
Applicant Contact |
C SCARBOROUGH |
Correspondent |
CARR-SCARBOROUGH MICROBIOLOGICALS, INC. |
P.O. BOX 1328 |
STONE MOUNTAIN,
GA
30086
|
|
Correspondent Contact |
C SCARBOROUGH |
Regulation Number | 866.2660
|
Classification Product Code |
|
Date Received | 03/16/1989 |
Decision Date | 04/12/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|