FDA product code LLG: Kit, Igg, Platelet Associated
LLG is the FDA product code for kit, igg, platelet associated. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under LLG, from 2 different applicants. The average 510(k) review took 86 days (median 86). FDA has posted 1 recall for LLG devices.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Igg, Platelet Associated |
| Device class | Class II |
| Regulation | 21 CFR 864.5425 |
| 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 LLG clearance
Top LLG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| General Diagnostics | 1 | 1984-07-02 |
| Applied Polytechnology, Inc. | 1 | 1984-04-19 |
Most recent LLG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K841465 | General Diagnostics | GENERAL DIAGNOSTICS PLATELET ANTIBODY | 1984-07-02 | 84 |
| K840257 | Applied Polytechnology, Inc. | RAPID IMMUNO-ASSAY SYS | 1984-04-19 | 87 |
Recalls for LLG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-08-02.
Frequently asked questions
What is FDA product code LLG?
LLG is the FDA product code for kit, igg, platelet associated. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel.
What device class is LLG?
Class II, regulation 21 CFR 864.5425. Typical premarket route: 510(k).
How long does a 510(k) take for product code LLG?
Across 2 cleared submissions the average was 86 days from receipt to decision (median 86).
Which companies have the most LLG clearances?
General Diagnostics (1); Applied Polytechnology, Inc. (1).
Have LLG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code LLG
- Run a recall and safety report across every LLG manufacturer
- Watch product code LLG 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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