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FDA 510(k)

UBAS

K-Number: K993941 · 2000-03-02

ApplicantMarukin Diagnostics
Decision Date2000-03-02
Product CodeKWX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBAS is the device name listed in this FDA 510(k) record. The listed applicant is Marukin Diagnostics. It received FDA 510(k) clearance on 2000-03-02 under 510(k) number K993941. The device is classified under product code KWX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UBAS?

UBAS is a medical device that received FDA 510(k) clearance on 2000-03-02. The listed applicant is Marukin Diagnostics. The 510(k) number is K993941.

When did UBAS receive FDA 510(k) clearance?

UBAS received FDA 510(k) clearance on 2000-03-02, under 510(k) number K993941.

Who is the listed applicant for UBAS?

The FDA 510(k) record lists Marukin Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UBAS?

The FDA product code for UBAS is KWX.

Related Devices (Code: KWX)

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.

K980525UBAS MANUAL METHOD AND UBAS AUTOMATED METHODMarukin Shoyu Co., Ltd.

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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