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FDA 510(k)

Hemo-Lyte C 製劑

K 號：K202508 · 2022-08-12

申請人Di-Chem, Inc.
決定日期2022-08-12
產品代碼KPO
諮詢委員會GU
決定相當於

器材摘要

Hemo-Lyte C Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Di-Chem, Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K202508. 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 Hemo-Lyte C Cartridge?

Hemo-Lyte C Cartridge is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Di-Chem, Inc.. The 510(k) number is K202508.

When did Hemo-Lyte C Cartridge receive FDA 510(k) clearance?

Hemo-Lyte C Cartridge received FDA 510(k) clearance on 2022-08-12, under 510(k) number K202508.

Who is the listed applicant for Hemo-Lyte C Cartridge?

The FDA 510(k) record lists Di-Chem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemo-Lyte C Cartridge?

The FDA product code for Hemo-Lyte C Cartridge is KPO.

相關臨床試驗

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其他以 Di-Chem, Inc. 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。

K171015西特瑞特

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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