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FDA 510(k)

Citryte

K-Number: K171015 · 2017-10-13

ApplicantDi-Chem, Inc.
Decision Date2017-10-13
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Citryte 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 2017-10-13 under 510(k) number K171015. 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 Citryte?

Citryte is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Di-Chem, Inc.. The 510(k) number is K171015.

When did Citryte receive FDA 510(k) clearance?

Citryte received FDA 510(k) clearance on 2017-10-13, under 510(k) number K171015.

Who is the listed applicant for Citryte?

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 Citryte?

The FDA product code for Citryte is KPO.

Other records listing Di-Chem, Inc. as applicant

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.

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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

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

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