Mardx Mitochondria Eia Test System
FDA 510(k) K950110 · Hogan & Hartson
510(k) numberK950110
Submission
- Device name
- Mardx Mitochondria Eia Test System
- Applicant
- Hogan & Hartson
Washington, D.C., DC, US - Received
- January 11, 1995
- Decision date
- May 15, 1995
- 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
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| 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 |
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| K973162 | Dual Radiation Targeting System DRTS DrapeIWE · Traditional | 11/20/1997SE |
| K950169 | Ribosomal P Eia Test SystemMQA · Traditional | 05/23/1996SE |
| K942389 | Trocars, Trocar Sleeves and Reduction SleevesHET · Traditional | 02/16/1996SE |
| K946217 | Cardiolipin M Eia Test SystemMID · Traditional | 01/24/1996SE |
| K946216 | Cardiolipin a Eia Test SystemMID · Traditional | 01/24/1996SE |
| K946215 | Cardiolipin G Eia Test SystemMID · Traditional | 01/24/1996SE |
| K946186 | CHAL-2500IPF · Traditional | 08/14/1995SN |
| K941566 | CompuspeakLLZ · Traditional | 06/30/1995SE |
Questions and answers
When was Mardx Mitochondria Eia Test System cleared by the FDA?
Mardx Mitochondria Eia Test System (K950110) received a 510(k) decision of Substantially Equivalent on May 15, 1995, 124 days after the submission was received.
What is the product code of K950110?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.