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FDA 510(k)

UROPAPER EIKEN GK

K-Number: K932363 · 1993-11-16

ApplicantTanabe U.S.A., Inc.
Decision Date1993-11-16
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UROPAPER EIKEN GK is the device name listed in this FDA 510(k) record. The listed applicant is Tanabe U.S.A., Inc.. It received FDA 510(k) clearance on 1993-11-16 under 510(k) number K932363. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROPAPER EIKEN GK?

UROPAPER EIKEN GK is a medical device that received FDA 510(k) clearance on 1993-11-16. The listed applicant is Tanabe U.S.A., Inc.. The 510(k) number is K932363.

When did UROPAPER EIKEN GK receive FDA 510(k) clearance?

UROPAPER EIKEN GK received FDA 510(k) clearance on 1993-11-16, under 510(k) number K932363.

Who is the listed applicant for UROPAPER EIKEN GK?

The FDA 510(k) record lists Tanabe U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROPAPER EIKEN GK?

The FDA product code for UROPAPER EIKEN GK is JIL.

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Other records listing Tanabe U.S.A., Inc. 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.

K932368UROPAPER EIKEN 6BK932365UROPAPER EIKEN AGK932366UROPAPER EIKEN HAGK931897UROPAPERK932369UROPAPER EIKEN 7K932364UROPAPER EIKEN GP

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Related Devices (Code: JIL)

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.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI 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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