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FDA 510(k)

PBS(-), Phosphate Buffered Saline

K-Number: K160863 · 2016-07-28

ApplicantKitazato Biopharma Co., Ltd.
Decision Date2016-07-28
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PBS(-), Phosphate Buffered Saline is a medical device manufactured by Kitazato Biopharma Co., Ltd.. It received FDA 510(k) clearance on 2016-07-28 under approval number K160863. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PBS(-), Phosphate Buffered Saline?

PBS(-), Phosphate Buffered Saline is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Kitazato Biopharma Co., Ltd.. The 510(k) number is K160863.

When was PBS(-), Phosphate Buffered Saline approved by the FDA?

PBS(-), Phosphate Buffered Saline received FDA 510(k) clearance on 2016-07-28, under approval number K160863.

What company makes PBS(-), Phosphate Buffered Saline?

PBS(-), Phosphate Buffered Saline is manufactured by Kitazato Biopharma Co., Ltd..

What is the FDA product code for PBS(-), Phosphate Buffered Saline?

The FDA product code for PBS(-), Phosphate Buffered Saline is MQL.

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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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