Monabrite Chlamydia Trach Culture Confirmation Tes
FDA 510(k) K854615 · Serono Diagnostics, Inc.
510(k) numberK854615
Submission
- Device name
- Monabrite Chlamydia Trach Culture Confirmation Tes
- Applicant
- Serono Diagnostics, Inc.
Bramtree, MA, US - Received
- November 18, 1985
- Decision date
- January 28, 1986
- 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 |
| K883776 | BTC Chlamydia Direct Specimen Test & Control SlideLKI · Traditional | Btc Corp. | 02/03/1989SE |
| K830342 | Culuture Set Chlamydia Isolation andLKI · Traditional | Immulok, Inc. | 05/04/1983SE |
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Questions and answers
When was Monabrite Chlamydia Trach Culture Confirmation Tes cleared by the FDA?
Monabrite Chlamydia Trach Culture Confirmation Tes (K854615) received a 510(k) decision of Substantially Equivalent on January 28, 1986, 71 days after the submission was received.
What is the product code of K854615?
The FDA product code is LKI – Antisera, Fluorescent, Chlamydia Spp., a Class I (low risk) device regulated under 21 CFR 866.3120.