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FDA 510(k)

HemoCare Bicarbonate Concentrate Set (BCS)

K-Number: K240920 · 2024-07-12

ApplicantDeka Research and Development
Decision Date2024-07-12
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HemoCare Bicarbonate Concentrate Set (BCS) is a medical device manufactured by Deka Research and Development. It received FDA 510(k) clearance on 2024-07-12 under approval number K240920. 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 HemoCare Bicarbonate Concentrate Set (BCS)?

HemoCare Bicarbonate Concentrate Set (BCS) is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Deka Research and Development. The 510(k) number is K240920.

When was HemoCare Bicarbonate Concentrate Set (BCS) approved by the FDA?

HemoCare Bicarbonate Concentrate Set (BCS) received FDA 510(k) clearance on 2024-07-12, under approval number K240920.

What company makes HemoCare Bicarbonate Concentrate Set (BCS)?

HemoCare Bicarbonate Concentrate Set (BCS) is manufactured by Deka Research and Development.

What is the FDA product code for HemoCare Bicarbonate Concentrate Set (BCS)?

The FDA product code for HemoCare Bicarbonate Concentrate Set (BCS) 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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