Immunochemical Determination of Transferrin
FDA 510(k) K884075 · Orion Diagnostica, Inc.
510(k) numberK884075
Submission
- Device name
- Immunochemical Determination of Transferrin
- Applicant
- Orion Diagnostica, Inc.
02101 Espoo, FI - Received
- September 27, 1988
- Decision date
- October 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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| K043125 | Orion Diagnostica Uniq Pinp RiaCIN · Traditional | 05/04/2005SE |
| K042625 | Quikread CRP Calibrator SetJJY · Traditional | 11/18/2004SE |
| 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 |
| K884040 | Immunochemical Determination of Immunoglobulin aCZP · Traditional | 10/19/1988SE |
Questions and answers
When was Immunochemical Determination of Transferrin cleared by the FDA?
Immunochemical Determination of Transferrin (K884075) received a 510(k) decision of Substantially Equivalent on October 19, 1988, 22 days after the submission was received.
What is the product code of K884075?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.