LIM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Screening, For D Positive Fetal Rbc'S
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7455
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FETAL D TECTION KIT (K980314) | Biopool Intl., Inc. | 1998-04-08 |
| GAMMA FETAL BLEED SCREENING TEST (K820647) | Gamma Biologicals, Inc. | 1982-05-12 |
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Every clearance here is in the API, with alerts when new ones post.