FDA product code LJO: Antigen, Iha, Cytomegalovirus
LJO is the FDA product code for antigen, iha, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel. FDA has cleared 12 510(k) submissions under LJO, from 10 different applicants. The average 510(k) review took 162 days (median 140).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Iha, Cytomegalovirus |
| Device class | Class II |
| Regulation | 21 CFR 866.3175 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LJO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 45 |
| 2021 | 1 | 102 |
Compare with all 510(k) review times · Search every LJO clearance
Top LJO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immucor, Inc. | 3 | 2021-03-22 |
| Diamedix Corp. | 1 | 2000-08-07 |
| Digene Corp. | 1 | 1998-09-29 |
| Instrumentation Laboratory CO | 1 | 1998-05-01 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1996-07-24 |
5 more applicants have LJO clearances. See the full list in Caduvo.
Most recent LJO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203612 | Immucor, Inc. | Capture-CMV | 2021-03-22 | 102 |
| K183571 | Immucor, Inc. | Capture-CMV | 2019-02-04 | 45 |
| K001767 | Diamedix Corp. | DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM | 2000-08-07 | 56 |
| K974901 | Digene Corp. | HYBRID CAPTURE SYSTEM CMV DNA ASSAY | 1998-09-29 | 272 |
| K974456 | Instrumentation Laboratory CO | CMVGEN | 1998-05-01 | 157 |
Recalls for LJO devices
openFDA lists no recalls for product code LJO.
Frequently asked questions
What is FDA product code LJO?
LJO is the FDA product code for antigen, iha, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel.
What device class is LJO?
Class II, regulation 21 CFR 866.3175. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJO?
Across 12 cleared submissions the average was 162 days from receipt to decision (median 140).
Which companies have the most LJO clearances?
Immucor, Inc. (3); Diamedix Corp. (1); Digene Corp. (1); Instrumentation Laboratory CO (1); E.I. Dupont DE Nemours & Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LJO
- Run a recall and safety report across every LJO manufacturer
- Watch product code LJO 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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