Reaads Dsdna Quantitative Test Kit, Model 022-001
FDA 510(k) K034013 · Corgenix, Inc.
510(k) numberK034013
Submission
- Device name
- Reaads Dsdna Quantitative Test Kit, Model 022-001
- Applicant
- Corgenix, Inc.
Westminster, CO, US - Received
- December 24, 2003
- Decision date
- January 8, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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Questions and answers
When was Reaads Dsdna Quantitative Test Kit, Model 022-001 cleared by the FDA?
Reaads Dsdna Quantitative Test Kit, Model 022-001 (K034013) received a 510(k) decision of Substantially Equivalent on January 8, 2004, 15 days after the submission was received.
What is the product code of K034013?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.