LKI — Antisera, Fluorescent, Chlamydia Spp. Class I
FDA product code LKI covers "Antisera, Fluorescent, Chlamydia Spp.", a Class I medical device regulated under 21 CFR 866.3120. Submissions are reviewed by the Microbiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKI
- Device Class
- Class I
- Regulation Number
- 866.3120
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K914953 | stellar bio systems | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | February 19, 1992 |
| K905531 | immco diagnostics | LUPUS(LE)-LATEX TEST | January 25, 1991 |
| K894625 | bion ent | CHLAMYDIA (LGV-1) | August 15, 1989 |
| K883776 | btc | BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE | February 3, 1989 |
| K854615 | serono diagnostics | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES | January 28, 1986 |
| K830342 | immulok | CULUTURE SET CHLAMYDIA ISOLATION AND | May 4, 1983 |