免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

CitriCon 液体和粉末（柠檬酸酸化的酸浓缩液），AcetiCon 液体和粉末（乙酸酸化的酸浓缩液或乙酸钠），BicarboCon 液体和粉末（碳酸浓缩液），RenaCon 液体和粉末（乙酸钠酸化的乙酸浓缩液）

K号: K180679 · 2018-12-07

申请人Global Scientific Technologies, LLC
决定日期2018-12-07
产品代码KPO
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

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 Concentrate with Na Acetate) is the device name listed in this FDA 510(k) record. The listed applicant is Global Scientific Technologies, LLC. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K180679. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 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 Concentrate with Na Acetate)?

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 Concentrate with Na Acetate) is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Global Scientific Technologies, LLC. The 510(k) number is K180679.

When did 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 Concentrate with Na Acetate) receive FDA 510(k) clearance?

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 Concentrate with Na Acetate) received FDA 510(k) clearance on 2018-12-07, under 510(k) number K180679.

Who is the listed applicant for 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 Concentrate with Na Acetate)?

The FDA 510(k) record lists Global Scientific Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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 Concentrate with Na Acetate)?

The FDA product code for 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 Concentrate with Na Acetate) is KPO.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：KPO）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260799尼普洛干酸浓缩液混合器Nipro Technical Solutions, IncoporatedK253462NaturaLyte® 干碳酸氢钠浓缩液（08-4112-2）Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby 透析液 RFP-404 (RFP-404-W)；Bicarby 透析液 RFP-403 (RFP-403-W)；Bicarby 透析液 RFP-403 (RFP-403-G)；Bicarby 透析液 RFP-453 (RFP-453-W)；Bicarby 透析液 RFP-453 (RFP-453-G)；Bicarby 透析液 RFP-454 (RFP-454-W)；Bicarby 透析液 RFP-454 (RFP-454-G)；Bicarby 透析液 RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby 透析液 RFP-402 (RFP-402-G)；Bicarby 透析液 RFP-400 (RFP-400-G)；Bicarby 透析液 RFP-407 (RFP-407-G)；Bicarby 透析液 RFP-401 (RFP-401-G)；Bicarby 透析液 RFP-404 (RFP-404-G)；Bicarby 透析液 RFP-456 (RFP-456-G)；Ci-Ca 透析液 2K (RFP-457-G)；Ci-Ca 透析液 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare 碳酸氢钠浓缩液套装（BCS）Deka Research and DevelopmentK233950pureFLOW 402（F00012067）；pureFLOW 406（F00012068）；pureFLOW 401（F00012069）；pureFLOW 400（F00012070）Fresenius Medical Care Renal Therapies Group, LLC

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

↑