FDA product code MLL: Hemoglobin C (Abnormal Hemoglobin Variant)
MLL is the FDA product code for hemoglobin c (abnormal hemoglobin variant). It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under MLL. The average 510(k) review took 577 days (median 577).
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobin C (Abnormal Hemoglobin Variant) |
| Device class | Class II |
| Regulation | 21 CFR 864.7415 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top MLL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Isolab, Inc. | 1 | 1994-01-27 |
Most recent MLL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923153 | Isolab, Inc. | HEMOCARD, HEMOGLOBIN C ASSAY | 1994-01-27 | 577 |
Recalls for MLL devices
openFDA lists no recalls for product code MLL.
Frequently asked questions
What is FDA product code MLL?
MLL is the FDA product code for hemoglobin c (abnormal hemoglobin variant). It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel.
What device class is MLL?
Class II, regulation 21 CFR 864.7415. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLL?
Across 1 cleared submissions the average was 577 days from receipt to decision (median 577).
Which companies have the most MLL clearances?
Isolab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MLL
- Run a recall and safety report across every MLL manufacturer
- Watch product code MLL 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.