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FDA 510(k)

Citric Complete Dry Citric Acid (45X)

K-Number: K171750 · 2018-03-06

ApplicantDimesol USA, LLC
Decision Date2018-03-06
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Citric Complete Dry Citric Acid (45X) is the device name listed in this FDA 510(k) record. The listed applicant is Dimesol USA, LLC. It received FDA 510(k) clearance on 2018-03-06 under 510(k) number K171750. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Citric Complete Dry Citric Acid (45X)?

Citric Complete Dry Citric Acid (45X) is a medical device that received FDA 510(k) clearance on 2018-03-06. The listed applicant is Dimesol USA, LLC. The 510(k) number is K171750.

When did Citric Complete Dry Citric Acid (45X) receive FDA 510(k) clearance?

Citric Complete Dry Citric Acid (45X) received FDA 510(k) clearance on 2018-03-06, under 510(k) number K171750.

Who is the listed applicant for Citric Complete Dry Citric Acid (45X)?

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

What is the FDA product code for Citric Complete Dry Citric Acid (45X)?

The FDA product code for Citric Complete Dry Citric Acid (45X) is KPO.

Related Devices (Code: KPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253462NaturaLyte® Dry Bicarbonate Concentrate (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, LLCK243786Bicarby 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, 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, LLCK233213NxStage PureFlow SolutionNxstage Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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