The following data is part of a premarket notification filed by Hamilton Co. with the FDA for Prp-1 Reversed Phase Resin.
Device ID | K832197 |
510k Number | K832197 |
Device Name: | PRP-1 REVERSED PHASE RESIN |
Classification | Liquid Chromatography, Adsorbent |
Applicant | HAMILTON CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DMZ |
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 | 1983-08-12 |