Device Classification Name |
Kit, Identification, Yeast
|
510(k) Number |
K943621 |
Device Name |
RAPID YEAST PLUS SYSTEM |
Applicant |
INNOVATIVE DIAGNOSTIC SYSTEMS, INC. |
3404 OAKCLIFF RD. #C-1 |
ATLANTA,
GA
30340
|
|
Applicant Contact |
LOUIS A ERIQUEZ, PH.D. |
Correspondent |
INNOVATIVE DIAGNOSTIC SYSTEMS, INC. |
3404 OAKCLIFF RD. #C-1 |
ATLANTA,
GA
30340
|
|
Correspondent Contact |
LOUIS A ERIQUEZ, PH.D. |
Regulation Number | 866.2660
|
Classification Product Code |
|
Date Received | 07/27/1994 |
Decision Date | 01/27/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|