| Device Classification Name |
Quality Control Slides
|
| 510(k) Number |
K924893 |
| Device Name |
MICROSPORIDIUM CONTROL SLIDE |
| Applicant |
| Scientific Device Laboratory, Inc. |
| 508 Zenith Dr. |
|
Glenview,
IL
60025
|
|
| Applicant Contact |
STEWART LIPTON |
| Correspondent |
| Scientific Device Laboratory, Inc. |
| 508 Zenith Dr. |
|
Glenview,
IL
60025
|
|
| Correspondent Contact |
STEWART LIPTON |
| Regulation Number | 866.2660 |
| Classification Product Code |
|
| Date Received | 09/28/1992 |
| Decision Date | 01/15/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Microbiology
|
| 510k Review Panel |
Microbiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|