The following data is part of a premarket notification filed by Hamilton Co. with the FDA for Hc40/hc75 Prepacked Colums.
Device ID | K832198 |
510k Number | K832198 |
Device Name: | HC40/HC75 PREPACKED COLUMS |
Classification | Ion-exchange Chromatography |
Applicant | HAMILTON CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DJY |
CFR Regulation Number | 862.2230 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-07 |
Decision Date | 1983-08-12 |