Culuture Set Chlamydia Isolation and
FDA 510(k) K830342 · Immulok, Inc.
510(k) numberK830342
Submission
- Device name
- Culuture Set Chlamydia Isolation and
- Applicant
- Immulok, Inc.
Mchenry, IL, US - Received
- February 1, 1983
- Decision date
- May 4, 1983
- 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 |
| K854615 | Monabrite Chlamydia Trach Culture Confirmation TesLKI · Traditional | Serono Diagnostics, Inc. | 01/28/1986SE |
More from Serono Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830971 | Herpes Simplex Virus Typing ReagentsGQL · Traditional | 06/30/1983SE |
| K830250 | CVT Viral TransportsJTW · Traditional | 02/28/1983SE |
| K823304 | Riaset Prolactin Ria KitCFT · Traditional | 12/22/1982SE |
| K822785 | Fluoroset Immunofluorescent AntibodyGQL · Traditional | 11/29/1982SE |
| K823055 | Flouroset Immunofluorescent AntibodyDHN · Traditional | 11/05/1982SE |
| K822606 | Cytomegalovirus Antobody IggLIN · Traditional | 11/01/1982SE |
| K822605 | Toxoplasma Gondii Antibody IggLJK · Traditional | 10/27/1982SE |
| K822607 | Antinuclear Antobody Cell SubstrateDHN · Traditional | 09/17/1982SE |
| K821567 | Immulok CulturesetGQL · Traditional | 06/25/1982SE |
| K821411 | Histoset Immunoperofidase TissueGQL · Traditional | 06/25/1982SE |
Questions and answers
When was Culuture Set Chlamydia Isolation and cleared by the FDA?
Culuture Set Chlamydia Isolation and (K830342) received a 510(k) decision of Substantially Equivalent on May 4, 1983, 92 days after the submission was received.
What is the product code of K830342?
The FDA product code is LKI – Antisera, Fluorescent, Chlamydia Spp., a Class I (low risk) device regulated under 21 CFR 866.3120.