Liquichek ANTI-SCL-70 Control, Positive, Catalog #116
FDA 510(k) K024226 · Bio-Rad
510(k) numberK024226
Submission
- Device name
- Liquichek ANTI-SCL-70 Control, Positive, Catalog #116
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- December 23, 2002
- Decision date
- January 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K171061 | MRSASelect IIJSO · Traditional | 12/28/2017SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
Questions and answers
When was Liquichek ANTI-SCL-70 Control, Positive, Catalog #116 cleared by the FDA?
Liquichek ANTI-SCL-70 Control, Positive, Catalog #116 (K024226) received a 510(k) decision of Substantially Equivalent on January 10, 2003, 18 days after the submission was received.
What is the product code of K024226?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.