Elia SCL-70S Immunoassay
FDA 510(k) K140493 · Phadia GmbH
510(k) numberK140493
Submission
- Device name
- Elia SCL-70S Immunoassay
- Applicant
- Phadia GmbH
Portage, MI, US - Received
- February 27, 2014
- Decision date
- October 30, 2014
- 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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Questions and answers
When was Elia SCL-70S Immunoassay cleared by the FDA?
Elia SCL-70S Immunoassay (K140493) received a 510(k) decision of Substantially Equivalent on October 30, 2014, 245 days after the submission was received.
What is the product code of K140493?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.