The following data is part of a premarket notification filed by Cooperbiomedical, Inc. with the FDA for Immuno-plate Iv Radial Immuno Test Kit/alpha-1 Ant.
| Device ID | K863868 |
| 510k Number | K863868 |
| Device Name: | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT |
| Classification | Alpha-1-antichymotrypsin, Antigen, Antiserum, Control |
| Applicant | COOPERBIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Brewster, Phd |
| Correspondent | Brewster, Phd COOPERBIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | DFF |
| CFR Regulation Number | 866.5080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-03 |
| Decision Date | 1987-02-13 |