510(k) K180679
- Device
- CitriCon Liquid And Powder (Acid Concentrate Acidified With Citric Acid), AcetiCon Liquid And Powder (Acid Concentrate Acidified With Acetic Acid Or Na Di Acetate), BicarboCon Liquid And Powder (Bicarb Concentrate), RenaCon Liquid And Powder (Acetate
- Applicant
- Global Scientific Technologies, LLC
- 510(k) number
- K180679
- Product code
- KPO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-12-07
- Date received
- 2018-03-15
- Regulation
- 876.5820
- Classification name
- Dialysate Concentrate For Hemodialysis (liquid Or Powder)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- William J. Griswold, Jr.
- Address
- 151 Old Jones Rd. Greer SC US 29651 29651
FDA Registration Numbers#
- 3005162618
- 3032828299
- 3010242164
- 9611823
- 9610270
- 3038195011
- 1225714
- 3019131
- 1528807
- 1954315
- 9610725
- 3003768032
- 3027241826
- 3035708507
- 1651896
- 3016096143
- 3043014136
- 2029275
- 3003591774
- 9616277
- 1652176
- 2183415
- 1056186
- 8030639
- 1713747
- 3003464075
- 3007137482
- 3013764800
- 3027592507
- 2431908
- 1835498
- 3013546115
- 3012364195
- 3005578748
- 3004176176
Source Documents#
Other 510(k) Records For Product Code KPO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-01-29 |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-09-09 |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-04 |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | Deka Research and Development | 2024-07-12 |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-10 |
| K233213 | NxStage PureFlow Solution | Nxstage Medical, Inc. | 2024-01-18 |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-01 |
| K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | 2023-08-04 |
| K221652 | NIKKICART | Renal Care Dialysis Solutions, S.A. DE C.V. | 2023-03-03 |
| K202508 | Hemo-Lyte C Cartridge | Di-Chem, Inc. | 2022-08-12 |
| K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2022-05-12 |
| K212052 | HMB32 Dialysis Solution | Haemopharm Biofluids S.R.L. | 2021-07-23 |
| K193155 | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | Nipro Renal Solutions USA, Corp. | 2020-11-25 |
| K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2020-05-08 |
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2020-04-24 |
Legacy Summary#
summary
FDA Review#
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