| Device Classification Name |
Device, General Purpose, Microbiology, Diagnostic
|
| 510(k) Number |
K853745 |
| Device Name |
MIC-CONCEPT VIEWBOX |
| Applicant |
| Microtech Medical Systems, Inc. |
| 401 Laredo St., Unit 1 |
|
Aurora,
CO
80011
|
|
| Applicant Contact |
JERRY G KILGORE |
| Correspondent |
| Microtech Medical Systems, Inc. |
| 401 Laredo St., Unit 1 |
|
Aurora,
CO
80011
|
|
| Correspondent Contact |
JERRY G KILGORE |
| Regulation Number | 866.2660 |
| Classification Product Code |
|
| Date Received | 09/09/1985 |
| Decision Date | 09/19/1985 |
| 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
|
|
|