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FDA 510(k)

檸檬酸完整液態檸檬酸濃縮液

K 號：K223431 · 2023-08-04

申請人Nipro Renal Solutions USA, Corp.
決定日期2023-08-04
產品代碼KPO
諮詢委員會GU
決定相當於

器材摘要

Citric Complete Liquid Citric Acid Concentrate is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Renal Solutions USA, Corp.. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K223431. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Citric Complete Liquid Citric Acid Concentrate?

Citric Complete Liquid Citric Acid Concentrate is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Nipro Renal Solutions USA, Corp.. The 510(k) number is K223431.

When did Citric Complete Liquid Citric Acid Concentrate receive FDA 510(k) clearance?

Citric Complete Liquid Citric Acid Concentrate received FDA 510(k) clearance on 2023-08-04, under 510(k) number K223431.

Who is the listed applicant for Citric Complete Liquid Citric Acid Concentrate?

The FDA 510(k) record lists Nipro Renal Solutions USA, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Citric Complete Liquid Citric Acid Concentrate?

The FDA product code for Citric Complete Liquid Citric Acid Concentrate is KPO.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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其他以 Nipro Renal Solutions USA, Corp. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K193155尼普羅乾淨乾酸濃縮劑，適用於血液透析

相關器械（代碼：KPO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260799尼普羅乾性酸濃縮混合器Nipro Technical Solutions, IncoporatedK253462NaturaLyte®乾性重碳濃縮液（08-4112-2）Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby 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, LLCK243786雙碳比透析液 RFP-402 (RFP-402-G)；雙碳比透析液 RFP-400 (RFP-400-G)；雙碳比透析液 RFP-407 (RFP-407-G)；雙碳比透析液 RFP-401 (RFP-401-G)；雙碳比透析液 RFP-404 (RFP-404-G)；雙碳比透析液 RFP-456 (RFP-456-G)；鋅鐵離子透析液 2K (RFP-457-G)；鋅鐵離子透析液 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067)；pureFLOW 406 (F00012068)；pureFLOW 401 (F00012069)；pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC

官方來源

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