| Device Classification Name |
photometric method, magnesium |
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|---|---|---|---|---|
| 510(k) Number | K991717 | |||
| Device Name | CARESIDE MG | |||
| Applicant |
|
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| Applicant Contact | kenneth b asarch | |||
| Correspondent |
|
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| 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) |
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| Regulation Medical Specialty |
Clinical Chemistry |
|||
| 510k Review Panel |
Clinical Chemistry |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |