The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Diacrom * Heparin.
| Device ID | K832373 |
| 510k Number | K832373 |
| Device Name: | DIACROM * HEPARIN |
| Classification | Assay, Heparin |
| Applicant | WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-18 |
| Decision Date | 1983-09-29 |