Immuno-Plate IV Radial Immuno Test KIT/ALPHA-1 Ant
FDA 510(k) K863868 · Cooper Biomedical, Inc.
510(k) numberK863868
Submission
- Device name
- Immuno-Plate IV Radial Immuno Test KIT/ALPHA-1 Ant
- Applicant
- Cooper Biomedical, Inc.
Malvern, PA, US - Received
- October 3, 1986
- Decision date
- February 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DFF – Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5080
- Specialty
- Immunology
More from Cooper Biomedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864512 | Immuno-Plate IV Radial Immuno Test Kit/Human HaptoDAD · 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 |
| K851287 | Radial Immunodiffusion Plates TransferrinDDG · Traditional | 05/24/1985SE |
Questions and answers
When was Immuno-Plate IV Radial Immuno Test KIT/ALPHA-1 Ant cleared by the FDA?
Immuno-Plate IV Radial Immuno Test KIT/ALPHA-1 Ant (K863868) received a 510(k) decision of Substantially Equivalent on February 13, 1987, 133 days after the submission was received.
What is the product code of K863868?
The FDA product code is DFF – Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5080.