| Device Classification Name |
Electrode, Ion-Specific, Chloride
|
| 510(k) Number |
K790653 |
| Device Name |
NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER |
| Applicant |
| Nova Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Nova Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 862.1170 |
| Classification Product Code |
|
| Date Received | 04/05/1979 |
| Decision Date | 06/15/1979 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|