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FDA 510(k)

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate

K-Number: K192209 · 2020-05-08

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2020-05-08
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-05-08 under approval number K192209. 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 Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate?

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate is a medical device that received FDA 510(k) clearance on 2020-05-08. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K192209.

When was Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate approved by the FDA?

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate received FDA 510(k) clearance on 2020-05-08, under approval number K192209.

What company makes Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate?

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate?

The FDA product code for Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate is KPO.

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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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