| Device Classification Name |
Device, Parasite Concentration
|
| 510(k) Number |
K853715 |
| Device Name |
PARA CON TM |
| Applicant |
| Para Scientific Co. |
| 4155 Melissa Dr. |
|
Lake Oswego,
OR
97034
|
|
| Applicant Contact |
BONNY J CARLSON |
| Correspondent |
| Para Scientific Co. |
| 4155 Melissa Dr. |
|
Lake Oswego,
OR
97034
|
|
| Correspondent Contact |
BONNY J CARLSON |
| Regulation Number | 866.2900 |
| Classification Product Code |
|
| Date Received | 09/04/1985 |
| Decision Date | 10/02/1985 |
| 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
|
|
|