Sero/Tex Le Test
FDA 510(k) K821385 · Texas Immunology, Inc.
510(k) numberK821385
Submission
- Device name
- Sero/Tex Le Test
- Applicant
- Texas Immunology, Inc.
Mchenry, IL, US - Received
- May 10, 1982
- Decision date
- May 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K914801 | Immunowell Dsdna Antibody TestDHC · Traditional | General Biometrics, Inc. | 12/09/1991SE |
| K885048 | Access R-Clone Ana Profile AssayDHC · Traditional | Lipogen, Inc. | 01/24/1989SE |
| K872910 | Immuno/SleDHC · Traditional | Immunostics Co., Inc. | 08/12/1987SE |
| K810981 | Anti Ndna Immunoflourescent Test SysDHC · Traditional | Immuno-Products Industries | 04/29/1981SE |
| 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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| K912246 | Target Microalbuminuria TestJIR · Traditional | 07/19/1991SE |
| K910073 | Target Aso TestGTQ · Traditional | 05/21/1991SE |
| K904105 | V-Trend Target RF TestDHR · Traditional | 10/15/1990SE |
| K892231 | V-Trend Target CRP TestDCN · Traditional | 04/21/1989SE |
| K890423 | V-Trend Target CRP TestDCK · Traditional | 02/17/1989SE |
Questions and answers
When was Sero/Tex Le Test cleared by the FDA?
Sero/Tex Le Test (K821385) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 18 days after the submission was received.
What is the product code of K821385?
The FDA product code is DHC – System, Test, Systemic Lupus Erythematosus, a Class II (moderate risk) device regulated under 21 CFR 866.5820.