BTC Chlamydia Direct Specimen Test & Control Slide
FDA 510(k) K883776 · Btc Corp.
510(k) numberK883776
Submission
- Device name
- BTC Chlamydia Direct Specimen Test & Control Slide
- Applicant
- Btc Corp.
Suisun, CA, US - Received
- September 6, 1988
- Decision date
- February 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K914953 | Ifa for Chlamydia Trachomatis Igg AntibodyLKI · Traditional | Stellar Bio Systems, Inc. | 02/19/1992SE |
| K905531 | Lupus(Le)-Latex TestLKI · Traditional | Immco Diagnostics, Inc. | 01/25/1991SE |
| K894625 | Chlamydia (LGV-1)LKI · Traditional | Bion Ent., Ltd. | 08/15/1989SE |
| 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 |
Questions and answers
When was BTC Chlamydia Direct Specimen Test & Control Slide cleared by the FDA?
BTC Chlamydia Direct Specimen Test & Control Slide (K883776) received a 510(k) decision of Substantially Equivalent on February 3, 1989, 150 days after the submission was received.
What is the product code of K883776?
The FDA product code is LKI – Antisera, Fluorescent, Chlamydia Spp., a Class I (low risk) device regulated under 21 CFR 866.3120.