FDA product code LJC: Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
LJC is the FDA product code for enzyme linked immunoabsorbent assay, (chlamydiae group). It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel. FDA has cleared 67 510(k) submissions under LJC, from 32 different applicants. The average 510(k) review took 145 days (median 105). FDA has posted 7 recalls for LJC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) |
| Device class | Class I |
| Regulation | 21 CFR 866.3120 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LJC clearance
Top LJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 10 | 1996-05-30 |
| Syva Co. | 7 | 1993-09-30 |
| Ortho Diagnostic Systems, Inc. | 4 | 1992-08-11 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 4 | 1991-01-14 |
| Eastman Kodak Company | 4 | 1990-06-20 |
27 more applicants have LJC clearances. See the full list in Caduvo.
Most recent LJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032330 | Thermo Biostar, Inc. | CT OIA | 2004-03-02 | 217 |
| K033865 | Dakocytomation, Ltd. | IDEIA PCE CHLAMYDIA | 2004-01-21 | 40 |
| K033079 | Trinity Biotech USA | CHLAMYDIA IGG ELISA TEST SYSTEM | 2003-11-26 | 58 |
| K982210 | Dade Behring, Inc. | MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA | 1998-07-09 | 16 |
| K962558 | Armkel, LLC | CHLAMYDIA IGG ELISA TEST SYSTEM | 1997-02-24 | 238 |
Recalls for LJC devices
7 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code LJC?
LJC is the FDA product code for enzyme linked immunoabsorbent assay, (chlamydiae group). It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel.
What device class is LJC?
Class I, regulation 21 CFR 866.3120. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJC?
Across 67 cleared submissions the average was 145 days from receipt to decision (median 105).
Which companies have the most LJC clearances?
Abbott Laboratories (10); Syva Co. (7); Ortho Diagnostic Systems, Inc. (4); Kallestad Diag, A Div. of Erbamont, Inc. (4); Eastman Kodak Company (4).
Have LJC devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LJC
- Run a recall and safety report across every LJC manufacturer
- Watch product code LJC 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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