AIA-PACK B12 ASSAY
Device Facts
| Record ID | K964348 |
|---|---|
| Device Name | AIA-PACK B12 ASSAY |
| Applicant | Tosoh Medics, Inc. |
| Product Code | CDD · Clinical Chemistry |
| Decision Date | Jan 13, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1810 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
