Access R-Clone Ana Profile Assay
FDA 510(k) K885048 · Lipogen, Inc.
510(k) numberK885048
Submission
- Device name
- Access R-Clone Ana Profile Assay
- Applicant
- Lipogen, Inc.
Knoxville, TN, US - Received
- December 7, 1988
- Decision date
- January 24, 1989
- 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
Other 510(k)s with product code DHC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001352 | Reaads Igg Anti-Prothrombin Semi-Quantitative Test KitDHC · Traditional | Corgenix, Inc. | 04/09/2001SE |
| K001398 | Reaads Igm Anti-Prothrombin Semi-Quantitative Test KitDHC · Traditional | Corgenix, Inc. | 03/30/2001SE |
| K930421 | Elias Dsdna AbsDHC · Traditional | Elias U.S.A., Inc. | 03/10/1993SE |
| K930247 | Human A-Ds DNA Eia Kit for Diagnostic UseDHC · Traditional | The Binding Site, Ltd. | 03/10/1993SE |
| K914801 | Immunowell Dsdna Antibody TestDHC · Traditional | General Biometrics, Inc. | 12/09/1991SE |
| K872910 | Immuno/SleDHC · Traditional | Immunostics Co., Inc. | 08/12/1987SE |
| K821385 | Sero/Tex Le TestDHC · Traditional | Texas Immunology, Inc. | 05/28/1982SE |
| 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 |
More from Cordis Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K902636 | Lipogen Rheumelisa Dsdna AssayLRY · Traditional | 06/28/1990SE |
| K895997 | Rheumelisa Assay for RNP AutoantibodiesLKO · Traditional | 11/06/1989SE |
| K895996 | Rheumelisa Assay for SM AutoantibodiesLKP · Traditional | 11/06/1989SE |
| K895995 | Rheumelisa Assay for Ss-B/La AutoantibodiesLJM · Traditional | 10/27/1989SE |
| K895994 | Rheumelisa Assay for Ss-A/Ro AutoantibodiesLJM · Traditional | 10/24/1989SE |
| K894659 | Ana Antisera Control KitDHN · Traditional | 09/21/1989SE |
| K892421 | Modified Access R-Clone Ana/Rf Screening TestLJM · Traditional | 05/09/1989SE |
| K882740 | Access R-Clone(Tm) Ana/Rf Screening AssayLKJ · Traditional | 09/22/1988SE |
| K880254 | SM Antibody Test KitLKP · Traditional | 04/06/1988SE |
| K874195 | La Antibody Test KitLJM · Traditional | 03/11/1988SE |
Questions and answers
When was Access R-Clone Ana Profile Assay cleared by the FDA?
Access R-Clone Ana Profile Assay (K885048) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 48 days after the submission was received.
What is the product code of K885048?
The FDA product code is DHC – System, Test, Systemic Lupus Erythematosus, a Class II (moderate risk) device regulated under 21 CFR 866.5820.