Combion Skin Test
FDA 510(k) K830688 · Nicholas H. Maganias
510(k) numberK830688
Submission
- Device name
- Combion Skin Test
- Applicant
- Nicholas H. Maganias
Mchenry, IL, US - Received
- March 4, 1983
- Decision date
- March 31, 1983
- 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 |
| K820390 | Histoset Immunoperoxidase Tissure KitLKH · Traditional | Immulok, Inc. | 04/14/1982SE |
More from Immulok, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833999 | Combion Skin Test - Four ProngSCL · Traditional | 09/05/1984SE |
Questions and answers
When was Combion Skin Test cleared by the FDA?
Combion Skin Test (K830688) received a 510(k) decision of Substantially Equivalent on March 31, 1983, 27 days after the submission was received.
What is the product code of K830688?
The FDA product code is LKH – Antisera, Immunoperoxidase, Chlamydia Spp., a Class I (low risk) device regulated under 21 CFR 866.3120.