EliA Rib-P
FDA 510(k) K202540 · Phadia AB
510(k) numberK202540
Submission
- Device name
- EliA Rib-P
- Applicant
- Phadia AB
Uppsala, SE - Received
- September 2, 2020
- Decision date
- September 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQA – Anti-Ribosomal P Antibodies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code MQA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K024151 | El-Ana Profiles: Anti-Ribosomal Protein PMQA · Traditional | Theratest Laboratories, Inc. | 02/06/2003SE |
| K981237 | Quanta Lite Ribosome P ElisaMQA · Traditional | Inova Diagnostics, Inc. | 06/05/1998SE |
| K950169 | Ribosomal P Eia Test SystemMQA · Traditional | Hogan & Hartson | 05/23/1996SE |
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| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…MVM · Traditional | 03/01/2019SE |
| K183007 | EliA SmDP ImmunoassayLKP · Traditional | 12/24/2018SE |
Questions and answers
When was EliA Rib-P cleared by the FDA?
EliA Rib-P (K202540) received a 510(k) decision of Substantially Equivalent on September 13, 2021, 376 days after the submission was received.
What is the product code of K202540?
The FDA product code is MQA – Anti-Ribosomal P Antibodies, a Class II (moderate risk) device regulated under 21 CFR 866.5100.