FDA product code LKI: Antisera, Fluorescent, Chlamydia Spp.
LKI is the FDA product code for antisera, fluorescent, chlamydia spp.. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under LKI, from 6 different applicants. The average 510(k) review took 82 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, Chlamydia Spp. |
| 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 LKI clearance
Top LKI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stellar Bio Systems, Inc. | 1 | 1992-02-19 |
| Immco Diagnostics, Inc. | 1 | 1991-01-25 |
| Bion Ent., Ltd. | 1 | 1989-08-15 |
| Btc Corp. | 1 | 1989-02-03 |
| Serono Diagnostics, Inc. | 1 | 1986-01-28 |
1 more applicants have LKI clearances. See the full list in Caduvo.
Most recent LKI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914953 | Stellar Bio Systems, Inc. | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | 1992-02-19 | 106 |
| K905531 | Immco Diagnostics, Inc. | LUPUS(LE)-LATEX TEST | 1991-01-25 | 46 |
| K894625 | Bion Ent., Ltd. | CHLAMYDIA (LGV-1) | 1989-08-15 | 26 |
| K883776 | Btc Corp. | BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE | 1989-02-03 | 150 |
| K854615 | Serono Diagnostics, Inc. | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES | 1986-01-28 | 71 |
Recalls for LKI devices
openFDA lists no recalls for product code LKI.
Frequently asked questions
What is FDA product code LKI?
LKI is the FDA product code for antisera, fluorescent, chlamydia spp.. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel.
What device class is LKI?
Class I, regulation 21 CFR 866.3120. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKI?
Across 6 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most LKI clearances?
Stellar Bio Systems, Inc. (1); Immco Diagnostics, Inc. (1); Bion Ent., Ltd. (1); Btc Corp. (1); Serono Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LKI
- Run a recall and safety report across every LKI manufacturer
- Watch product code LKI 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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