AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
FDA 510(k) K153117 · Aesku Systems GmbH&Co.Kg
510(k) numberK153117
Submission
- Device name
- AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
- Applicant
- Aesku Systems GmbH&Co.Kg
Wendelsheim, DE - Received
- October 28, 2015
- Decision date
- July 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code DHN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | Zeus Scientific, Inc. | 04/29/2022SE |
| K172745 | ImmuGlo HEp-2 Elite IFADHN · Traditional | Immco Diagnostics, Inc. | 06/05/2018SE |
| K160265 | Image Navigator by Immuno ConceptsDHN · Traditional | Immuno Concepts, N.A. , Ltd. | 06/17/2016SE |
| K141827 | Euroimmun Ifa 40: HEP-20-10; Europattern Microscope and SoftwareDHN · Traditional | Euroimmun Us, Inc. | 04/17/2015SE |
| K150155 | NOVA Lite DAPI ANA KitDHN · Traditional | Inova Diagnostics, Inc. | 04/08/2015SE |
| 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 |
| K024220 | Liquichek Autoimmune Negative Control, Catalog #130DHN · Traditional | Bio-Rad | 01/17/2003SE |
Questions and answers
When was AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM cleared by the FDA?
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (K153117) received a 510(k) decision of Substantially Equivalent on July 28, 2016, 274 days after the submission was received.
What is the product code of K153117?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.