LKI
6 FDA 510(k) clearances · Product code
92 daysmedian time to decision
150 days90th percentile
6clearances measured
FDA profile
- Official device name
- Antisera, Fluorescent, Chlamydia Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (K914953) | Stellar Bio Systems, Inc. | 1992-02-19 |
| LUPUS(LE)-LATEX TEST (K905531) | Immco Diagnostics, Inc. | 1991-01-25 |
| CHLAMYDIA (LGV-1) (K894625) | Bion Ent., Ltd. | 1989-08-15 |
| BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE (K883776) | Btc Corp. | 1989-02-03 |
| MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES (K854615) | Serono Diagnostics, Inc. | 1986-01-28 |
| CULUTURE SET CHLAMYDIA ISOLATION AND (K830342) | Immulok, Inc. | 1983-05-04 |
Track LKI automatically
Every clearance here is in the API, with alerts when new ones post.