Device Classification Name |
electrode, ion specific, sodium
|
510(k) Number |
K800216 |
Device Name |
SODIUM/POTASSIUM CONDITIONING REAGENT |
Applicant |
FISHER SCIENTIFIC CO., LLC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
FISHER SCIENTIFIC CO., LLC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1665
|
Classification Product Code |
|
Date Received | 02/04/1980 |
Decision Date | 02/26/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|