The following data is part of a premarket notification filed by Iso-data, Inc. with the FDA for Iso-data Immunoassay Network System.
| Device ID | K843365 |
| 510k Number | K843365 |
| Device Name: | ISO-DATA IMMUNOASSAY NETWORK SYSTEM |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | ISO-DATA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1984-09-27 |