Image Navigator by Immuno Concepts
FDA 510(k) K160265 · Immuno Concepts, N.A. , Ltd.
510(k) numberK160265
Submission
- Device name
- Image Navigator by Immuno Concepts
- Applicant
- Immuno Concepts, N.A. , Ltd.
Sacramento, CA, US - Received
- February 2, 2016
- Decision date
- June 17, 2016
- 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
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More from Bio-Rad
| 510(k) | Device | Decision |
|---|---|---|
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemKTL · Traditional | 05/26/2023SE |
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsDBL · Traditional | 10/19/2018SE |
| K030775 | Auto I.D. JO-1, SCL-70 & Pcna Positive Control SerumLKJ · Abbreviated | 05/12/2003SE |
Questions and answers
When was Image Navigator by Immuno Concepts cleared by the FDA?
Image Navigator by Immuno Concepts (K160265) received a 510(k) decision of Substantially Equivalent on June 17, 2016, 136 days after the submission was received.
What is the product code of K160265?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.