FDA product code LGL: Assay, Bart'S, Hemoglobin
LGL is the FDA product code for assay, bart's, hemoglobin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under LGL. The average 510(k) review took 110 days (median 110).
Classification
| Field | Value |
|---|---|
| Device name | Assay, Bart'S, Hemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.7500 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LGL clearance
Top LGL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Isolab, Inc. | 2 | 1981-05-29 |
Most recent LGL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810976 | Isolab, Inc. | ALPHA-THAL SCREEN TM CONTROL | 1981-05-29 | 49 |
| K801771 | Isolab, Inc. | ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT | 1981-01-16 | 172 |
Recalls for LGL devices
openFDA lists no recalls for product code LGL.
Frequently asked questions
What is FDA product code LGL?
LGL is the FDA product code for assay, bart's, hemoglobin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel.
What device class is LGL?
Class II, regulation 21 CFR 864.7500. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGL?
Across 2 cleared submissions the average was 110 days from receipt to decision (median 110).
Which companies have the most LGL clearances?
Isolab, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LGL
- Run a recall and safety report across every LGL manufacturer
- Watch product code LGL 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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