JBB
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Solubility, Hemoglobin, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7825
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SICKLE CELL TEST KIT (K932872) | Histo-Med, Inc. | 1993-08-16 |
| SICKLE CELL SOLUBILITY TEST KIT (K895745) | Simmler, Inc. | 1989-11-29 |
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Every clearance here is in the API, with alerts when new ones post.