GHC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tube, Sedimentation Rate
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6700
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2018: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| SALMONELLA IFA* (K885114) | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 | + Add |
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Every clearance here is in the API, with alerts when new ones post.