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FDA 510(k)

UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD

K-Number: K980525 · 1998-04-15

ApplicantMarukin Shoyu Co., Ltd.
Decision Date1998-04-15
Product CodeKWX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Marukin Shoyu Co., Ltd.. It received FDA 510(k) clearance on 1998-04-15 under 510(k) number K980525. 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 MANUAL METHOD AND UBAS AUTOMATED METHOD?

UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD is a medical device that received FDA 510(k) clearance on 1998-04-15. The listed applicant is Marukin Shoyu Co., Ltd.. The 510(k) number is K980525.

When did UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD receive FDA 510(k) clearance?

UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD received FDA 510(k) clearance on 1998-04-15, under 510(k) number K980525.

Who is the listed applicant for UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD?

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

What is the FDA product code for UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD?

The FDA product code for UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD is KWX.

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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.

K993941UBASMarukin Diagnostics

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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