510(k) K172745
- Device
- ImmuGlo HEp-2 Elite IFA
- Applicant
- IMMCO Diagnostics, Inc.
- 510(k) number
- K172745
- Product code
- DHN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-05
- Date received
- 2017-09-12
- Regulation
- 866.5100
- Classification name
- Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kevin Lawson
- Address
- 60 Pineview Dr. Buffalo NY US 14228 14228
FDA Registration Numbers#
- 3003825930
- 3032523590
- 3032705
- 3003268355
- 3004973408
- 2914537
- 3026753391
- 2915274
- 2182595
- 3007118747
- 1181055
- 3007361513
- 2026994
- 3012348571
- 2016706
- 2242436
- 3015376545
- 2029372
- 1419968
- 2918768
- 3010127294
Source Documents#
Other 510(k) Records For Product Code DHN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | Zeus Scientific, Inc. | 2022-04-29 |
| K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | Aesku Systems GmbH&Co.Kg | 2016-07-28 |
| K160265 | Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | 2016-06-17 |
| K141827 | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | Euroimmun Us, Inc. | 2015-04-17 |
| K150155 | NOVA Lite DAPI ANA Kit | Inova Diagnostics, Inc. | 2015-04-08 |
| K131791 | IFA 40: HEP-20-10 | Euroimmun US | 2014-02-26 |
| K120889 | AESKUSLIDES ANA HEP-2 | Aesku Diagnostics | 2012-10-15 |
| K070763 | EUROIMMUN ANA IFA: HEP-20-10 | Euroimmun Us, LLC | 2007-05-22 |
| K042680 | RHIGENE HEP-ANA TEST SYSTEM | Corgenix, Inc. | 2004-11-19 |
| K024220 | LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 | Bio-Rad | 2003-01-17 |
| K024217 | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 | Bio-Rad | 2003-01-15 |
| K024221 | LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 | Bio-Rad | 2003-01-15 |
| K024222 | LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 | Bio-Rad | 2003-01-15 |
| K024224 | LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 | Bio-Rad | 2003-01-15 |
| K024225 | LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 | Bio-Rad | 2003-01-15 |
Legacy Summary#
summary
FDA Review#
Decision Summary