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 | K192017 |
| 510k Number | K192017 |
| 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 | 2019-07-29 |
| Decision Date | 2020-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861101887 | K192017 | 000 |
| 10840861101709 | K192017 | 000 |
| 10840861101693 | K192017 | 000 |
| 10840861101686 | K192017 | 000 |
| 10840861101679 | K192017 | 000 |
| 10840861101662 | K192017 | 000 |
| 10840861101655 | K192017 | 000 |
| 10840861101648 | K192017 | 000 |
| 10840861101631 | K192017 | 000 |
| 10840861101624 | K192017 | 000 |
| 10840861101716 | K192017 | 000 |
| 10840861101723 | K192017 | 000 |
| 00840861101870 | K192017 | 000 |
| 00840861101863 | K192017 | 000 |
| 00840861101856 | K192017 | 000 |
| 00840861101849 | K192017 | 000 |
| 00840861101832 | K192017 | 000 |
| 10840861101808 | K192017 | 000 |
| 10840861101754 | K192017 | 000 |
| 10840861101747 | K192017 | 000 |
| 10840861101730 | K192017 | 000 |
| 10840861101617 | K192017 | 000 |