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FDA 510(k)

Hemo-Lyte C Cartridge

K-Number: K202508 · 2022-08-12

ApplicantDi-Chem, Inc.
Decision Date2022-08-12
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

K171015Citryte

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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