The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Citrasate Liquid Acid Concentrate, Naturalyte Liquid Acid Concentrate.
| Device ID | K212620 |
| 510k Number | K212620 |
| Device Name: | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2022-05-12 |