FDA product code LGO: Test, Leukocyte Typing
LGO is the FDA product code for test, leukocyte typing. It is a Class I device, regulated under 21 CFR 864.7675 and reviewed by the Hematology panel. FDA has cleared 5 510(k) submissions under LGO, from 4 different applicants. The average 510(k) review took 175 days (median 155).
Classification
| Field | Value |
|---|---|
| Device name | Test, Leukocyte Typing |
| Device class | Class I |
| Regulation | 21 CFR 864.7675 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LGO clearance
Top LGO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hyland Therapeutic Div., Travenol Laboratories | 2 | 1977-04-06 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 1 | 1990-03-23 |
| Molecular Biosystems, Inc. | 1 | 1988-08-12 |
| Calbiochem-Behring Corp. | 1 | 1979-08-03 |
Most recent LGO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894947 | Kallestad Diag, A Div. of Erbamont, Inc. | PLATELIA TOXO IGG KIT | 1990-03-23 | 232 |
| K874544 | Molecular Biosystems, Inc. | SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT | 1988-08-12 | 283 |
| K791118 | Calbiochem-Behring Corp. | HLA CONTROL SERA | 1979-08-03 | 49 |
| K761009 | Hyland Therapeutic Div., Travenol Laboratories | LYMPHOCYTE TYPING, POSITIVE CONTROL | 1977-04-06 | 155 |
| K761008 | Hyland Therapeutic Div., Travenol Laboratories | LYMPHOCYTE TYPING, NEGATIVE CONTROL | 1977-04-06 | 155 |
Recalls for LGO devices
openFDA lists no recalls for product code LGO.
Frequently asked questions
What is FDA product code LGO?
LGO is the FDA product code for test, leukocyte typing. It is a Class I device, regulated under 21 CFR 864.7675 and reviewed by the Hematology panel.
What device class is LGO?
Class I, regulation 21 CFR 864.7675. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LGO?
Across 5 cleared submissions the average was 175 days from receipt to decision (median 155).
Which companies have the most LGO clearances?
Hyland Therapeutic Div., Travenol Laboratories (2); Kallestad Diag, A Div. of Erbamont, Inc. (1); Molecular Biosystems, Inc. (1); Calbiochem-Behring Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LGO
- Run a recall and safety report across every LGO manufacturer
- Watch product code LGO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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