The following data is part of a premarket notification filed by Hamilton Co. with the FDA for Chrom-prep.
| Device ID | K832201 |
| 510k Number | K832201 |
| Device Name: | CHROM-PREP |
| Classification | Chromatography (liquid, Gel), Clinical Use |
| Applicant | HAMILTON CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZR |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-07 |
| Decision Date | 1983-08-16 |