Varelisa Recombi Ana Screen, Model 12 596
FDA 510(k) K083188 · Phadia US, Inc.
510(k) numberK083188
Submission
- Device name
- Varelisa Recombi Ana Screen, Model 12 596
- Applicant
- Phadia US, Inc.
Portage, MI, US - Received
- October 29, 2008
- Decision date
- March 13, 2009
- 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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| 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 |
| K040953 | Aeskulisa Ana HEP-2LJM · Traditional | Aesku, Inc. | 06/23/2004SE |
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Questions and answers
When was Varelisa Recombi Ana Screen, Model 12 596 cleared by the FDA?
Varelisa Recombi Ana Screen, Model 12 596 (K083188) received a 510(k) decision of Substantially Equivalent on March 13, 2009, 135 days after the submission was received.
What is the product code of K083188?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.