HEP-2 Ana Test System with If-Aim Technology
FDA 510(k) K001556 · The Binding Site, Ltd.
510(k) numberK001556
Submission
- Device name
- HEP-2 Ana Test System with If-Aim Technology
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- May 18, 2000
- Decision date
- August 21, 2000
- 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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Questions and answers
When was HEP-2 Ana Test System with If-Aim Technology cleared by the FDA?
HEP-2 Ana Test System with If-Aim Technology (K001556) received a 510(k) decision of Substantially Equivalent on August 21, 2000, 95 days after the submission was received.
What is the product code of K001556?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.