The following data is part of a premarket notification filed by Applied Polytechnology, Inc. with the FDA for Rapid Immuno-assay Sys.
| Device ID | K840257 |
| 510k Number | K840257 |
| Device Name: | RAPID IMMUNO-ASSAY SYS |
| Classification | Kit, Igg, Platelet Associated |
| Applicant | APPLIED POLYTECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LLG |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-23 |
| Decision Date | 1984-04-19 |