Igg Anti-Ndna Fluorescent Test System; Model # 3040G
FDA 510(k) K013432 · Immuno Concepts, Inc.
510(k) numberK013432
Submission
- Device name
- Igg Anti-Ndna Fluorescent Test System; Model # 3040G
- Applicant
- Immuno Concepts, Inc.
Sacramento, CA, US - Received
- October 15, 2001
- Decision date
- November 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTL – Anti-Dna Indirect Immunofluorescent Solid Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K990916 | Indirect Fluorescence Assay for Anti-Native DNA Igg AntibodyKTL · Traditional | Stellar Bio Systems, Inc. | 04/21/1999SE |
| K930987 | Crithidia Lucilliae DS DNA Kit (Diagnostic Use)KTL · Traditional | The Binding Site, Ltd. | 08/10/1993SE |
| K905386 | Distat Anti-Dsdna KitKTL · Traditional | Shield Diagnostics, Ltd. | 12/13/1990SE |
| K864275 | Anti-Ndna Antibody Test KitKTL · Traditional | Cappel Diagnostics, Inc. | 12/15/1986SE |
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| K963275 | Relisa Ena Single Well Screen Antibody Test SystemLLL · Traditional | 09/13/1996SE |
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Questions and answers
When was Igg Anti-Ndna Fluorescent Test System; Model # 3040G cleared by the FDA?
Igg Anti-Ndna Fluorescent Test System; Model # 3040G (K013432) received a 510(k) decision of Substantially Equivalent on November 29, 2001, 45 days after the submission was received.
What is the product code of K013432?
The FDA product code is KTL – Anti-Dna Indirect Immunofluorescent Solid Phase, a Class II (moderate risk) device regulated under 21 CFR 866.5100.