Access R-Clone(Tm) Ana/Rf Screening Assay
FDA 510(k) K882740 · Lipogen, Inc.
510(k) numberK882740
Submission
- Device name
- Access R-Clone(Tm) Ana/Rf Screening Assay
- Applicant
- Lipogen, Inc.
Knoxville, TN, US - Received
- July 1, 1988
- Decision date
- September 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LKJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210902 | EliA Ro52, EliA Ro60LKJ · Traditional | Phadia AB | 07/27/2022SE |
| K113610 | Ana-Screen with MDSSLKJ · Special | Bio-Rad Laboratories | 07/09/2012SE |
| K082759 | Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia Ro ImmunoassayLKJ · Traditional | Phadia US, Inc. | 04/10/2009SE |
| K081104 | Aeskulisa Ana HEP-2, Ref 30-7115USLKJ · Traditional | Aesku Diagnostics | 05/02/2008SE |
| K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…LKJ · Traditional | Bio-Rad Laboratories, Inc. | 12/20/2004SE |
| K042416 | Athena Multi-Lyte Ana-Ii Test SystemLKJ · Special | Zeus Scientific, Inc. | 10/08/2004SE |
| K034013 | Reaads Dsdna Quantitative Test Kit, Model 022-001LKJ · Special | Corgenix, Inc. | 01/08/2004SE |
| K030775 | Auto I.D. JO-1, SCL-70 & Pcna Positive Control SerumLKJ · Abbreviated | Immuno Concepts, N.A. , Ltd. | 05/12/2003SE |
| K024232 | Liquichek Anti-Ss-B Control, Positive, Catalog #113LKJ · Traditional | Bio-Rad | 01/17/2003SE |
| K024218 | Liquichek Anti-Ss-A Control, Positive, Catalog #114LKJ · Traditional | Bio-Rad | 01/17/2003SE |
More from Bio-Rad
| 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 |
| K885048 | Access R-Clone Ana Profile AssayDHC · Traditional | 01/24/1989SE |
| 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(Tm) Ana/Rf Screening Assay cleared by the FDA?
Access R-Clone(Tm) Ana/Rf Screening Assay (K882740) received a 510(k) decision of Substantially Equivalent on September 22, 1988, 83 days after the submission was received.
What is the product code of K882740?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.