Rhigene Hep-Ana Test System
FDA 510(k) K042680 · Corgenix, Inc.
510(k) numberK042680
Submission
- Device name
- Rhigene Hep-Ana Test System
- Applicant
- Corgenix, Inc.
Des Plaines, IL, US - Received
- September 29, 2004
- Decision date
- November 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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Questions and answers
When was Rhigene Hep-Ana Test System cleared by the FDA?
Rhigene Hep-Ana Test System (K042680) received a 510(k) decision of Substantially Equivalent on November 19, 2004, 51 days after the submission was received.
What is the product code of K042680?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.