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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 a medical device manufactured by Di-Chem, Inc.. It received FDA 510(k) clearance on 2022-08-12 under approval 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. It is manufactured by Di-Chem, Inc.. The 510(k) number is K202508.

When was Hemo-Lyte C Cartridge approved by the FDA?

Hemo-Lyte C Cartridge received FDA 510(k) clearance on 2022-08-12, under approval number K202508.

What company makes Hemo-Lyte C Cartridge?

Hemo-Lyte C Cartridge is manufactured by Di-Chem, Inc..

What is the FDA product code for Hemo-Lyte C Cartridge?

The FDA product code for Hemo-Lyte C Cartridge is KPO.

Other Devices by Di-Chem, Inc.

K171015Citryte

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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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