Tina-Quant [A] Transferrin
FDA 510(k) K871896 · Boehringer Mannheim Corp.
510(k) numberK871896
Submission
- Device name
- Tina-Quant [A] Transferrin
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- May 15, 1987
- Decision date
- June 15, 1987
- 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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| 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 |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Tina-Quant [A] Transferrin cleared by the FDA?
Tina-Quant [A] Transferrin (K871896) received a 510(k) decision of Substantially Equivalent on June 15, 1987, 31 days after the submission was received.
What is the product code of K871896?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.