Lab-Tek Ana Test Kit
FDA 510(k) K792184 · Miles Laboratories, Inc.
510(k) numberK792184
Submission
- Device name
- Lab-Tek Ana Test Kit
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- October 29, 1979
- Decision date
- November 30, 1979
- 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
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 |
| 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 |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Lab-Tek Ana Test Kit cleared by the FDA?
Lab-Tek Ana Test Kit (K792184) received a 510(k) decision of Substantially Equivalent on November 30, 1979, 32 days after the submission was received.
What is the product code of K792184?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.