Transferrin
FDA 510(k) K190495 · Biosystems S.A.
510(k) numberK190495
Submission
- Device name
- Transferrin
- Applicant
- Biosystems S.A.
Barcelona, ES - Received
- February 28, 2019
- Decision date
- March 16, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K120236 | Transferrin Kit for Use on the SpaplusDDG · Traditional | The Binding Site Group , Ltd. | 02/13/2013SE |
| K080634 | Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494…DDG · Traditional | Beckman Coulter, Inc. | 08/11/2008SE |
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| K063086 | Transferrin, Specical Calibrator, Specitrol and Specitrol High ControlsDDG · Traditional | Thermo Electron OY | 08/08/2007SE |
| K063766 | Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model#…DDG · Traditional | Good Biotech Corp. | 04/23/2007SE |
| K063663 | Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…DDG · Traditional | Dade Behring, Inc. | 03/21/2007SE |
| K063322 | Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control…DDG · Traditional | Dade Behring, Inc. | 01/24/2007SE |
| K053075 | N Antisera to Human TransferrinDDG · Traditional | Dade Behring, Inc. | 03/16/2006SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K192730 | Calcium-Cresolphthalein, Glucose, Urea/Bun-UvCHW · Traditional | 09/09/2020SE |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT…JFJ · Traditional | 05/02/2019SE |
| K170901 | Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, BA400CIX · Traditional | 04/13/2018SE |
Questions and answers
When was Transferrin cleared by the FDA?
Transferrin (K190495) received a 510(k) decision of Substantially Equivalent on March 16, 2020, 382 days after the submission was received.
What is the product code of K190495?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.