DHY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ng4m(A), Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5065
- Medical specialty
- Immunology
- Adverse events (MAUDE)
- 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| LIGHTNING DIALYZER (K810871) | Clintox Laboratories, Inc. | 1981-07-10 | + Add |
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