Immunochemistry Sys Urine Transferrin Reagent
FDA 510(k) K963976 · Beckman Instruments, Inc.
510(k) numberK963976
Submission
- Device name
- Immunochemistry Sys Urine Transferrin Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- October 4, 1996
- Decision date
- March 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code DDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240987 | Access sTfRDDG · Traditional | Beckman Coulter, Inc. | 07/03/2024SE |
| K190495 | TransferrinDDG · Traditional | Biosystems S.A. | 03/16/2020SE |
| K182095 | Tina-quant Transferrin ver.2 (urine application)DDG · Traditional | Roche Diagnostics Operations (Rdo) | 11/05/2018SE |
| 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 |
| K081299 | Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…DDG · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/08/2008SE |
| 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 |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Immunochemistry Sys Urine Transferrin Reagent cleared by the FDA?
Immunochemistry Sys Urine Transferrin Reagent (K963976) received a 510(k) decision of Substantially Equivalent on March 19, 1997, 166 days after the submission was received.
What is the product code of K963976?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.