Radial Immunodiffusion Plates Transferrin
FDA 510(k) K851287 · Cooper Biomedical, Inc.
510(k) numberK851287
Submission
- Device name
- Radial Immunodiffusion Plates Transferrin
- Applicant
- Cooper Biomedical, Inc.
Malvern, PA, US - Received
- April 1, 1985
- Decision date
- May 24, 1985
- 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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| K081299 | Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…DDG · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/08/2008SE |
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| 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 |
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More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864512 | Immuno-Plate IV Radial Immuno Test Kit/Human HaptoDAD · Traditional | 02/13/1987SE |
| K863868 | Immuno-Plate IV Radial Immuno Test KIT/ALPHA-1 AntDFF · Traditional | 02/13/1987SE |
| K863301 | Demand Total ProteinCEK · Traditional | 09/26/1986SE |
| K861926 | Worthington HDL Precipitating Reagent SetLBR · Traditional | 06/27/1986SE |
| K854130 | Demand Ethyl AlcoholDIC · Traditional | 11/05/1985SE |
| K853949 | Demand Acid Phosphatase ReagentCKB · Traditional | 10/16/1985SE |
| K852262 | Assist Clinical Chemistry AnalyzerJJE · Traditional | 06/25/1985SE |
| K851285 | Radial Immunodiffusion Plates CSF Igg & CSF AlbumiDCF · Traditional | 06/17/1985SE |
| K851284 | Radial Immuno-Diffusion Plates Iga, Igd, Igg & IgmCZP · Traditional | 06/11/1985SE |
| K851286 | Radial Immunodiffusion Plates C3 & C4CZW · Traditional | 06/05/1985SE |
Questions and answers
When was Radial Immunodiffusion Plates Transferrin cleared by the FDA?
Radial Immunodiffusion Plates Transferrin (K851287) received a 510(k) decision of Substantially Equivalent on May 24, 1985, 53 days after the submission was received.
What is the product code of K851287?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.