The following data is part of a premarket notification filed by Icl Scientific with the FDA for Enzymune System I.
| Device ID | K822465 |
| 510k Number | K822465 |
| Device Name: | ENZYMUNE SYSTEM I |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-16 |
| Decision Date | 1982-09-14 |