MESACUP-2 Test Cenp-B
FDA 510(k) K040200 · Rhigene, Inc.
510(k) numberK040200
Submission
- Device name
- MESACUP-2 Test Cenp-B
- Applicant
- Rhigene, Inc.
Des Plaines, IL, US - Received
- January 29, 2004
- Decision date
- March 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM · Traditional | Phadia AB | 11/27/2018SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | Immco Diagnostics, Inc. | 03/11/2016SE |
| K140493 | Elia SCL-70S ImmunoassayLJM · Traditional | Phadia GmbH | 10/30/2014SE |
| K123880 | Quanta Flash CentromereLJM · Traditional | Inova Diagnostics, Inc. | 02/07/2014SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | Gold Standard Diagnostics | 01/28/2014SE |
| K131185 | Ana Screen Elisa (Igg)LJM · Traditional | Euroimmun US | 07/15/2013SE |
| K083188 | Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional | Phadia US, Inc. | 03/13/2009SE |
| K050967 | Varelisa Recombi CTD Screen, Model 13096LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 06/28/2005SE |
| K050625 | Varelisa Recombi Ana Profile, Model 18496LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 04/26/2005SE |
| K041102 | Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional | Immco Diagnostics, Inc. | 10/26/2004SE |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K040711 | Mesacup Test PR-3MOB · Traditional | 04/02/2004SE |
| K040586 | Mesacup Test Mpo, Model 11053MOB · Traditional | 03/22/2004SE |
| K033528 | MESACUP-2 Test JO-1, Model 10756LLL · Traditional | 12/22/2003SE |
| K031308 | Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760DBM · Traditional | 09/26/2003SE |
| K022017 | Rhigene MESACUP-2 Test RNP, Model M7741LKO · Traditional | 08/14/2002SE |
| K022018 | Rhigene Ana Elisa Test System, Model K7560LJM · Special | 07/05/2002SE |
| K011068 | Rhigene Ndna Test System for Imagetiter, Model CL100LKTL · Traditional | 04/11/2002SE |
| K000336 | Rhigene DSG-1 & DSG-3 Elisa Test System, Model 7680 ENBO · Traditional | 06/09/2000SE |
| K000755 | Rhigene MESACUP2 Test- SMLKP · Traditional | 05/09/2000SE |
| K000752 | Rhigene MESACUP2 Test- RNPLKO · Traditional | 05/09/2000SE |
Questions and answers
When was MESACUP-2 Test Cenp-B cleared by the FDA?
MESACUP-2 Test Cenp-B (K040200) received a 510(k) decision of Substantially Equivalent on March 4, 2004, 35 days after the submission was received.
What is the product code of K040200?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.