Aeskuslides Ana HEP-2
FDA 510(k) K120889 · Aesku Diagnostics
510(k) numberK120889
Submission
- Device name
- Aeskuslides Ana HEP-2
- Applicant
- Aesku Diagnostics
Pedricktown, NJ, US - Received
- March 23, 2012
- Decision date
- October 15, 2012
- 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 |
| 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 |
| 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 |
More from Bio-Rad
| 510(k) | Device | Decision |
|---|---|---|
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB · Traditional | 03/23/2018SE |
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit…LSW · Traditional | 02/16/2018SE |
| K132082 | Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-CheckMST · Traditional | 12/05/2013SE |
| K091859 | Aesku PR3MOB · Traditional | 06/03/2010SE |
| K091860 | Aeskulisa Mpo, Model 30-7303USMOB · Traditional | 02/23/2010SE |
| K081251 | Modification to Aeskulisa DS DNA GLSW · Special | 05/13/2008SE |
| K081104 | Aeskulisa Ana HEP-2, Ref 30-7115USLKJ · Traditional | 05/02/2008SE |
| K052439 | Aeskulisa Glia a and Aeskulisa Glia GMST · Traditional | 02/07/2006SE |
| K041628 | Aeskulisa DS DNA GLSW · Traditional | 10/14/2004SE |
| K041753 | Aeskulisa Ena 6 SLLL · Traditional | 07/14/2004SE |
Questions and answers
When was Aeskuslides Ana HEP-2 cleared by the FDA?
Aeskuslides Ana HEP-2 (K120889) received a 510(k) decision of Substantially Equivalent on October 15, 2012, 206 days after the submission was received.
What is the product code of K120889?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.