Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH
FDA 510(k) K133404 · Phadia AB
510(k) numberK133404
Submission
- Device name
- Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH
- Applicant
- Phadia AB
Portage, MI, US - Received
- November 6, 2013
- Decision date
- February 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH cleared by the FDA?
Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH (K133404) received a 510(k) decision of Substantially Equivalent on February 24, 2014, 110 days after the submission was received.
What is the product code of K133404?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.