The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Level Ii Control Serum.
| Device ID | K821558 |
| 510k Number | K821558 |
| Device Name: | LEVEL II CONTROL SERUM |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | IRVINE SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-25 |
| Decision Date | 1982-07-02 |