The following data is part of a premarket notification filed by Berwick Medical Products, Inc. with the FDA for Iso-sep System.
| Device ID | K842018 |
| 510k Number | K842018 |
| Device Name: | ISO-SEP SYSTEM |
| Classification | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes |
| Applicant | BERWICK MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEX |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-18 |
| Decision Date | 1984-09-28 |