Enzyme Immunoassay Ana Screening Test Kit
FDA 510(k) K954723 · Helix Diagnostics, Inc.
510(k) numberK954723
Submission
- Device name
- Enzyme Immunoassay Ana Screening Test Kit
- Applicant
- Helix Diagnostics, Inc.
West Sacramento, CA, US - Received
- October 13, 1995
- Decision date
- December 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K001900 | Enzyme Immunoassay Anti-Ssdna Antibody TestLRM · Traditional | 09/11/2000SE |
| K000489 | Enzyme Immunoassay Anti-Centromere Antibody TestLLL · Traditional | 04/05/2000SE |
| K980337 | Diamedix Immunosimplicity Ana (Is-Ana) Screen Test SystemLJM · Traditional | 05/12/1998SE |
| K960091 | Enzyme Immunoassay Anti-Double Stranded DNA (Dsdna) Test KitLRM · Traditional | 03/20/1996SE |
| K954700 | Enzyme Immunoassay Lupus Screen Test KitLKJ · Traditional | 12/15/1995SE |
| K952253 | Enzyme Immunoassay Ena Plus Screening Test KitLLL · Traditional | 08/24/1995SE |
| K951850 | Enzyme Immunoassay ANTI-JO-1 Antibody Test KitLJM · Traditional | 07/18/1995SE |
| K951798 | Enzyme Immunoassay ANTI-SCI-70 Antibody Test KitLJM · Traditional | 07/17/1995SE |
| K940588 | Enzyme Immunoassay Anti-Sm/Rnp Antibody Test KitLKO · Traditional | 04/20/1994SE |
| K940510 | Enzyme Immunoassay Anti-Sm Antibody Test KitLKP · Traditional | 04/20/1994SE |
Questions and answers
When was Enzyme Immunoassay Ana Screening Test Kit cleared by the FDA?
Enzyme Immunoassay Ana Screening Test Kit (K954723) received a 510(k) decision of Substantially Equivalent on December 15, 1995, 63 days after the submission was received.
What is the product code of K954723?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.