ImmuGlo HEp-2 Elite IFA
FDA 510(k) K172745 · Immco Diagnostics, Inc.
510(k) numberK172745
Submission
- Device name
- ImmuGlo HEp-2 Elite IFA
- Applicant
- Immco Diagnostics, Inc.
Buffalo, NY, US - Received
- September 12, 2017
- Decision date
- June 5, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | Zeus Scientific, Inc. | 04/29/2022SE |
| K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMDHN · Traditional | Aesku Systems GmbH&Co.Kg | 07/28/2016SE |
| 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 |
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Questions and answers
When was ImmuGlo HEp-2 Elite IFA cleared by the FDA?
ImmuGlo HEp-2 Elite IFA (K172745) received a 510(k) decision of Substantially Equivalent on June 5, 2018, 266 days after the submission was received.
What is the product code of K172745?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.