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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 the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Biopharma Co., Ltd.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) 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. The listed applicant is Kitazato Biopharma Co., Ltd.. The 510(k) number is K160863.

When did PBS(-), Phosphate Buffered Saline receive FDA 510(k) clearance?

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

Who is the listed applicant for PBS(-), Phosphate Buffered Saline?

The FDA 510(k) record lists Kitazato Biopharma Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Kitazato Biopharma Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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