Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
FDA 510(k) K180202 · Immuno Concepts, N.A. , Ltd.
510(k) numberK180202
Submission
- Device name
- Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
- Applicant
- Immuno Concepts, N.A. , Ltd.
Sacramento, CA, US - Received
- January 24, 2018
- Decision date
- October 19, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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|---|---|---|---|
| K980312 | Nova Lite EndomysialDBL · Traditional | Inova Diagnostics, Inc. | 04/02/1998SE |
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| K971658 | Mouse Liver Kidney Stomach Diagnostic Test KitDBL · Traditional | Jay H. Geller | 05/23/1997SE |
| K963525 | Diastat Anti-Glomerular Basement Membrane KitDBL · Traditional | Shield Diagnostics, Ltd. | 11/07/1996SE |
| K955431 | Rit Liver, Kidney, Stomach Ifa KitDBL · Traditional | The Binding Site, Ltd. | 04/23/1996SE |
| K953495 | Eia Kit for the Detection of GBM AntibodiesDBL · Traditional | Scimedx Corp. | 04/10/1996SE |
| K944192 | Anti-Nuclear Antibody (Ana) Test Kit W/Rat LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
| K944191 | Anti-Nuclear Antibody(Ana) Test Kit W/Mouse LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
| K913360 | Anti-Reticulin Antibody (Ara) TestDBL · Traditional | Immco Diagnostics, Inc. | 09/26/1994SE |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemKTL · Traditional | 05/26/2023SE |
| K160265 | Image Navigator by Immuno ConceptsDHN · Traditional | 06/17/2016SE |
| K030775 | Auto I.D. JO-1, SCL-70 & Pcna Positive Control SerumLKJ · Abbreviated | 05/12/2003SE |
Questions and answers
When was Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts cleared by the FDA?
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts (K180202) received a 510(k) decision of Substantially Equivalent on October 19, 2018, 268 days after the submission was received.
What is the product code of K180202?
The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.