GHQ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Stain, Fetal Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7455
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CALTAG FETAL HEMOGLOBIN TEST (K990641) | Caltag Laboratories, Inc. | 1999-09-17 |
| FETAL HEMOGLOBIN (K892241) | Sure-Tech Diagnostic Associates, Inc. | 1989-05-17 |
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Every clearance here is in the API, with alerts when new ones post.