Ifa for Chlamydia Trachomatis Igg Antibody
FDA 510(k) K914953 · Stellar Bio Systems, Inc.
510(k) numberK914953
Submission
- Device name
- Ifa for Chlamydia Trachomatis Igg Antibody
- Applicant
- Stellar Bio Systems, Inc.
Columbia, MD, US - Received
- November 5, 1991
- Decision date
- February 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKI – Antisera, Fluorescent, Chlamydia Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Specialty
- Microbiology
Other 510(k)s with product code LKI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905531 | Lupus(Le)-Latex TestLKI · Traditional | Immco Diagnostics, Inc. | 01/25/1991SE |
| K894625 | Chlamydia (LGV-1)LKI · Traditional | Bion Ent., Ltd. | 08/15/1989SE |
| K883776 | BTC Chlamydia Direct Specimen Test & Control SlideLKI · Traditional | Btc Corp. | 02/03/1989SE |
| K854615 | Monabrite Chlamydia Trach Culture Confirmation TesLKI · Traditional | Serono Diagnostics, Inc. | 01/28/1986SE |
| K830342 | Culuture Set Chlamydia Isolation andLKI · Traditional | Immulok, Inc. | 05/04/1983SE |
More from Immulok, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992587 | Epstein-Barr Virus Early Antigen (Ebv-Ea) Igg Ifa Test SystemLSE · Traditional | 12/22/1999SE |
| K990916 | Indirect Fluorescence Assay for Anti-Native DNA Igg AntibodyKTL · Traditional | 04/21/1999SE |
| K990915 | Indirect Fluorescence Assay for Anti-Nuclear Antibodies Igg AntibodyDHN · Traditional | 04/21/1999SE |
| K905608 | Indirect Fluorescent Assay for Herpes Simplex 1GQL · Traditional | 11/07/1991SE |
| K900974 | Indirect Fluorescent Assay for (Ebv-Vca) Igg Anti.JRY · Traditional | 04/16/1990SE |
| K882835 | Indirect Fluorescent Assay for (HCMV)GQH · Traditional | 12/05/1988SE |
Questions and answers
When was Ifa for Chlamydia Trachomatis Igg Antibody cleared by the FDA?
Ifa for Chlamydia Trachomatis Igg Antibody (K914953) received a 510(k) decision of Substantially Equivalent on February 19, 1992, 106 days after the submission was received.
What is the product code of K914953?
The FDA product code is LKI – Antisera, Fluorescent, Chlamydia Spp., a Class I (low risk) device regulated under 21 CFR 866.3120.