FDA product code LJP: Antiserum, Fluorescent, Chlamydia Trachomatis
LJP is the FDA product code for antiserum, fluorescent, chlamydia trachomatis. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel. FDA has cleared 35 510(k) submissions under LJP, from 21 different applicants. The average 510(k) review took 86 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, Chlamydia Trachomatis |
| 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 LJP clearance
Top LJP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 7 | 1987-08-06 |
| Diagnostic Products Corp. | 2 | 1990-04-16 |
| Ortho Diagnostic Systems, Inc. | 2 | 1988-04-27 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 2 | 1988-03-17 |
| Orion Corp. | 2 | 1987-09-22 |
16 more applicants have LJP clearances. See the full list in Caduvo.
Most recent LJP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063675 | Diagnostic Hybrids, Inc. | DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT | 2007-09-24 | 287 |
| K941714 | Neogenex | CHLAMYDIA TRACHOMATIS ANTIGEN TEST | 1994-07-18 | 117 |
| K901243 | Cel Labs Pty, Ltd. | CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST | 1990-05-21 | 67 |
| K900870 | Diagnostic Products Corp. | PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST | 1990-04-16 | 51 |
| K895839 | Diagnostic Products Corp. | PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 | 1990-02-01 | 121 |
Recalls for LJP devices
openFDA lists no recalls for product code LJP.
Frequently asked questions
What is FDA product code LJP?
LJP is the FDA product code for antiserum, fluorescent, chlamydia trachomatis. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel.
What device class is LJP?
Class I, regulation 21 CFR 866.3120. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJP?
Across 35 cleared submissions the average was 86 days from receipt to decision (median 75).
Which companies have the most LJP clearances?
Syva Co. (7); Diagnostic Products Corp. (2); Ortho Diagnostic Systems, Inc. (2); Kallestad Diag, A Div. of Erbamont, Inc. (2); Orion Corp. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LJP
- Run a recall and safety report across every LJP manufacturer
- Watch product code LJP 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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