Histoset Immunoperoxidase Tissure Kit
FDA 510(k) K820390 · Immulok, Inc.
510(k) numberK820390
Submission
- Device name
- Histoset Immunoperoxidase Tissure Kit
- Applicant
- Immulok, Inc.
Mchenry, IL, US - Received
- February 10, 1982
- Decision date
- April 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKH – Antisera, Immunoperoxidase, Chlamydia Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Specialty
- Microbiology
Other 510(k)s with product code LKH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910644 | Ipazyme (TM) Chlamydia Igg-IgaLKH · Traditional | Savyon Diagnostics , Ltd. | 03/19/1991SE |
| K901975 | Ipazyme(Tm) Chlamydia True Igm(Tm)LKH · Traditional | Savyon Diagnostics , Ltd. | 03/08/1991SE |
| K882674 | Immu-Mark(Tm) Chlamydia Igg/Iga KitLKH · Traditional | Icn Immunobiologicals | 08/15/1989SE |
| K893669 | Cellmatics Shlamydia Detection SystemLKH · Traditional | Difco Laboratories, Inc. | 06/23/1989SE |
| K852869 | Selecticult-ChlamydiaLKH · Traditional | Scott Laboratories, Inc. | 09/19/1985SE |
| K842151 | Chlamydiae Immunoperoxidase Test KitLKH · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 07/20/1984SE |
| K830688 | Combion Skin TestLKH · Traditional | Nicholas H. Maganias | 03/31/1983SE |
More from Nicholas H. Maganias
| 510(k) | Device | Decision |
|---|---|---|
| K830971 | Herpes Simplex Virus Typing ReagentsGQL · Traditional | 06/30/1983SE |
| K830342 | Culuture Set Chlamydia Isolation andLKI · Traditional | 05/04/1983SE |
| 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 |
Questions and answers
When was Histoset Immunoperoxidase Tissure Kit cleared by the FDA?
Histoset Immunoperoxidase Tissure Kit (K820390) received a 510(k) decision of Substantially Equivalent on April 14, 1982, 63 days after the submission was received.
What is the product code of K820390?
The FDA product code is LKH – Antisera, Immunoperoxidase, Chlamydia Spp., a Class I (low risk) device regulated under 21 CFR 866.3120.