LGO
5 FDA 510(k) clearances · Product code
155 daysmedian time to decision
283 days90th percentile
5clearances measured
FDA profile
- Official device name
- Test, Leukocyte Typing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.7675
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PLATELIA TOXO IGG KIT (K894947) | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-23 |
| SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (K874544) | Molecular Biosystems, Inc. | 1988-08-12 |
| HLA CONTROL SERA (K791118) | Calbiochem-Behring Corp. | 1979-08-03 |
| LYMPHOCYTE TYPING, NEGATIVE CONTROL (K761008) | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 |
| LYMPHOCYTE TYPING, POSITIVE CONTROL (K761009) | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 |
Track LGO automatically
Every clearance here is in the API, with alerts when new ones post.