Orion Diagnostica Uniq Pinp Ria
FDA 510(k) K043125 · Orion Diagnostica, OY
510(k) numberK043125
Submission
- Device name
- Orion Diagnostica Uniq Pinp Ria
- Applicant
- Orion Diagnostica, OY
Espoo, FI - Received
- November 12, 2004
- Decision date
- May 4, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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| K942286 | Diarlex Rota-AdenoLIQ · Traditional | 12/14/1994SE |
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| K884147 | Immunochemical Determination of Immunoglobulin MDFT · Traditional | 10/27/1988SE |
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| K884075 | Immunochemical Determination of TransferrinDDG · Traditional | 10/19/1988SE |
| K884040 | Immunochemical Determination of Immunoglobulin aCZP · Traditional | 10/19/1988SE |
Questions and answers
When was Orion Diagnostica Uniq Pinp Ria cleared by the FDA?
Orion Diagnostica Uniq Pinp Ria (K043125) received a 510(k) decision of Substantially Equivalent on May 4, 2005, 173 days after the submission was received.
What is the product code of K043125?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.