The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for 72 Determ. Size Radial Immunodiffusion Test Alpha2.
| Device ID | K850683 |
| 510k Number | K850683 |
| Device Name: | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 |
| Classification | Alpha-2-macroglobulin, Antigen, Antiserum, Control |
| Applicant | KENT LABORATORIES, INC. 23404 N.E. 8TH ST. Redmond, WA 98053 |
| Contact | Allan H Jorgensen |
| Correspondent | Allan H Jorgensen KENT LABORATORIES, INC. 23404 N.E. 8TH ST. Redmond, WA 98053 |
| Product Code | DEB |
| CFR Regulation Number | 866.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-21 |
| Decision Date | 1985-11-27 |