Euroimmun Ana Ifa: HEP-20-10
FDA 510(k) K070763 · Euroimmun Us, LLC
510(k) numberK070763
Submission
- Device name
- Euroimmun Ana Ifa: HEP-20-10
- Applicant
- Euroimmun Us, LLC
Boonton Township, NJ, US - Received
- March 20, 2007
- Decision date
- May 22, 2007
- 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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| K120889 | Aeskuslides Ana HEP-2DHN · Traditional | Aesku Diagnostics | 10/15/2012SE |
| K042680 | Rhigene Hep-Ana Test SystemDHN · Traditional | Corgenix, Inc. | 11/19/2004SE |
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Questions and answers
When was Euroimmun Ana Ifa: HEP-20-10 cleared by the FDA?
Euroimmun Ana Ifa: HEP-20-10 (K070763) received a 510(k) decision of Substantially Equivalent on May 22, 2007, 63 days after the submission was received.
What is the product code of K070763?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.