Quikread CRP Calibrator Set
FDA 510(k) K042625 · Orion Diagnostica, OY
510(k) numberK042625
Submission
- Device name
- Quikread CRP Calibrator Set
- Applicant
- Orion Diagnostica, OY
Espoo, FI - Received
- September 27, 2004
- Decision date
- November 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…DCK · Traditional | 03/10/2016SE |
| K043125 | Orion Diagnostica Uniq Pinp RiaCIN · Traditional | 05/04/2005SE |
| K042442 | Quickread System: Quickread CRP Kit, Model 06085; Quickread 101 Instrument, Model 06088…DCK · Special | 09/24/2004SE |
| K942286 | Diarlex Rota-AdenoLIQ · Traditional | 12/14/1994SE |
| K914892 | Saliva-StimEGD · Traditional | 09/02/1992SE |
| K904655 | PylorisetLYR · Traditional | 10/21/1991SE |
| K884147 | Immunochemical Determination of Immunoglobulin MDFT · Traditional | 10/27/1988SE |
| K884074 | Immunochemical Determination of Immunoglobulin GDAH · Traditional | 10/27/1988SE |
| K884075 | Immunochemical Determination of TransferrinDDG · Traditional | 10/19/1988SE |
| K884040 | Immunochemical Determination of Immunoglobulin aCZP · Traditional | 10/19/1988SE |
Questions and answers
When was Quikread CRP Calibrator Set cleared by the FDA?
Quikread CRP Calibrator Set (K042625) received a 510(k) decision of Substantially Equivalent on November 18, 2004, 52 days after the submission was received.
What is the product code of K042625?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.