Device Classification Name |
photometric method, magnesium |
|||
---|---|---|---|---|
510(k) Number | K991717 | |||
Device Name | CARESIDE MG | |||
Applicant |
|
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Applicant Contact | kenneth b asarch | |||
Correspondent |
|
|||
Correspodent Contact | kenneth b asarch | |||
Regulation Number | 862.1495 | |||
Classification Product Code |
|
|||
Date Received | 05/20/1999 | |||
Decision Date | 08/10/1999 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Clinical Chemistry |
|||
510k Review Panel |
Clinical Chemistry |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |