Spq(Tm) Antibody Reagent Set II for TRF
FDA 510(k) K890563 · Atlantic Antibodies
510(k) numberK890563
Submission
- Device name
- Spq(Tm) Antibody Reagent Set II for TRF
- Applicant
- Atlantic Antibodies
Scarborough, ME, US - Received
- January 24, 1989
- Decision date
- March 3, 1989
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K892526 | SPQ TM Test System II for CRPDCK · Traditional | 05/09/1989SE |
| K891154 | Spq(Tm) Antibody Reagent Set II for Apo A-I/Apo BMSJ · Traditional | 03/16/1989SE |
| K890561 | Spq(Tm) Antibody Reagent Set II for IgmCFQ · Traditional | 02/23/1989SE |
| K890562 | Spq(Tm) Antibody Reagent Set II for HPTDAD · Traditional | 02/22/1989SE |
| K890416 | Spq(Tm) Antibody Reagent Set II for IggDEW · Traditional | 02/22/1989SE |
| K890564 | Spq(Tm) Antibody Reagent Set II for C4DBI · Traditional | 02/17/1989SE |
| K890417 | Spq(Tm) Antibody Reagent Set II for C3KTQ · Traditional | 02/17/1989SE |
| K890415 | Spq(Tm) Antibody Reagent Set II for AatDEM · Traditional | 02/17/1989SE |
| K890560 | Spq(Tm) Antibody Reagent Set II for IgaCZP · Traditional | 02/15/1989SE |
| K884298 | Spq(Tm) Test System for MicroalbuminJZJ · Traditional | 11/02/1988SE |
Questions and answers
When was Spq(Tm) Antibody Reagent Set II for TRF cleared by the FDA?
Spq(Tm) Antibody Reagent Set II for TRF (K890563) received a 510(k) decision of Substantially Equivalent on March 3, 1989, 38 days after the submission was received.
What is the product code of K890563?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.