Ana Test Kit
FDA 510(k) K811022 · Immuno-Diagnostic Products, Inc.
510(k) numberK811022
Submission
- Device name
- Ana Test Kit
- Applicant
- Immuno-Diagnostic Products, Inc.
- Received
- April 15, 1981
- Decision date
- April 23, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K131791 | Ifa 40: HEP-20-10DHN · Traditional | Euroimmun US | 02/26/2014SE |
| K120889 | Aeskuslides Ana HEP-2DHN · Traditional | Aesku Diagnostics | 10/15/2012SE |
| K070763 | Euroimmun Ana Ifa: HEP-20-10DHN · Traditional | Euroimmun Us, LLC | 05/22/2007SE |
| K042680 | Rhigene Hep-Ana Test SystemDHN · Traditional | Corgenix, Inc. | 11/19/2004SE |
More from Corgenix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K854207 | Ebv(Epstein-Barr Virus) Test KitGNP · Traditional | 04/24/1986SE |
| K811021 | HerpesGQN · Traditional | 11/05/1981SE |
| K811562 | Toxoplasmosis Test KitGLZ · Traditional | 07/16/1981SE |
| K801963 | CMV Test KitGQH · Traditional | 10/23/1980SE |
| K801959 | Fta-Abs TestJWL · Traditional | 10/23/1980SE |
| K801961 | Rf-Ii Test KitDHR · Traditional | 10/10/1980SE |
| K801960 | Anti-Ds/N-Dna Test KitDBL · Traditional | 10/10/1980SE |
Questions and answers
When was Ana Test Kit cleared by the FDA?
Ana Test Kit (K811022) received a 510(k) decision of Substantially Equivalent on April 23, 1981, 8 days after the submission was received.
What is the product code of K811022?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.