Human A-Ds DNA Eia Kit for Diagnostic Use
FDA 510(k) K930247 · The Binding Site, Ltd.
510(k) numberK930247
Submission
- Device name
- Human A-Ds DNA Eia Kit for Diagnostic Use
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- January 19, 1993
- Decision date
- March 10, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DHC – System, Test, Systemic Lupus Erythematosus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5820
- Specialty
- Immunology
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| K885048 | Access R-Clone Ana Profile AssayDHC · Traditional | Lipogen, Inc. | 01/24/1989SE |
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| K810226 | Sle Anti-N-Dna Latex TestDHC · Traditional | Icl Scientific | 02/09/1981SE |
| K800992 | Cordia NPDHC · Traditional | Cordis Corp. | 05/08/1980SE |
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Questions and answers
When was Human A-Ds DNA Eia Kit for Diagnostic Use cleared by the FDA?
Human A-Ds DNA Eia Kit for Diagnostic Use (K930247) received a 510(k) decision of Substantially Equivalent on March 10, 1993, 50 days after the submission was received.
What is the product code of K930247?
The FDA product code is DHC – System, Test, Systemic Lupus Erythematosus, a Class II (moderate risk) device regulated under 21 CFR 866.5820.