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FDA 510(k)

Rockwell Medical CitraPure Acid Concetrate

K-Number: K160847 · 2016-10-20

ApplicantRockwell Medical
Decision Date2016-10-20
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rockwell Medical CitraPure Acid Concetrate is a medical device manufactured by Rockwell Medical. It received FDA 510(k) clearance on 2016-10-20 under approval number K160847. 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 Rockwell Medical CitraPure Acid Concetrate?

Rockwell Medical CitraPure Acid Concetrate is a medical device that received FDA 510(k) clearance on 2016-10-20. It is manufactured by Rockwell Medical. The 510(k) number is K160847.

When was Rockwell Medical CitraPure Acid Concetrate approved by the FDA?

Rockwell Medical CitraPure Acid Concetrate received FDA 510(k) clearance on 2016-10-20, under approval number K160847.

What company makes Rockwell Medical CitraPure Acid Concetrate?

Rockwell Medical CitraPure Acid Concetrate is manufactured by Rockwell Medical.

What is the FDA product code for Rockwell Medical CitraPure Acid Concetrate?

The FDA product code for Rockwell Medical CitraPure Acid Concetrate 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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