The Theratest El-Ana Profiles
FDA 510(k) K914454 · Theratest Laboratories, Inc.
510(k) numberK914454
Submission
- Device name
- The Theratest El-Ana Profiles
- Applicant
- Theratest Laboratories, Inc.
Chicago, IL, US - Received
- October 7, 1991
- Decision date
- May 22, 1992
- 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 |
|---|---|---|
| K090753 | Theratest EL-ANTI-CCP/2NHX · Traditional | 03/05/2010SE |
| K090760 | Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120JZO · Traditional | 09/03/2009SE |
| K071692 | Theratest El-Ttg Iga/Igg and Theratest El-Glia Iga/Igg Test SystemsMVM · Traditional | 11/05/2007SE |
| K061376 | El-Anca: Anti-Mpo, ANTI-PR3, Anti-Mpo and ANTI-PR3MOB · Traditional | 07/20/2006SE |
| K060176 | El-Acl Screen; El-Acl Igm, Igg, IgaMID · Special | 02/07/2006SE |
| K051066 | Theratest El-Ana ProfilesLKP · Traditional | 10/07/2005SE |
| K040291 | El-Ana Profiles: Anti-ChromatinLJM · Traditional | 03/11/2004SE |
| K024151 | El-Ana Profiles: Anti-Ribosomal Protein PMQA · Traditional | 02/06/2003SE |
| K024031 | The Theratest El-Ana Profiles: Anti-CentromereLJM · Traditional | 02/06/2003SE |
| K002559 | El-Ana PROFILES-2K1LJM · Traditional | 09/12/2000SE |
Questions and answers
When was The Theratest El-Ana Profiles cleared by the FDA?
The Theratest El-Ana Profiles (K914454) received a 510(k) decision of Substantially Equivalent on May 22, 1992, 228 days after the submission was received.
What is the product code of K914454?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.