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FDA 510(k)

ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS

K-Number: K861733 · 1986-07-25

ApplicantKyoto Diagnostics, Inc.
Decision Date1986-07-25
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Kyoto Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-07-25 under 510(k) number K861733. 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 ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS?

ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1986-07-25. The listed applicant is Kyoto Diagnostics, Inc.. The 510(k) number is K861733.

When did ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS receive FDA 510(k) clearance?

ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS received FDA 510(k) clearance on 1986-07-25, under 510(k) number K861733.

Who is the listed applicant for ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS?

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

What is the FDA product code for ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS?

The FDA product code for ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS is JIL.

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Other records listing Kyoto Diagnostics, 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.

K843003GLUCOSE AUTO& STAT GA-1120K842750OSMOTIC PRESSURE AUTO & STAT OM-6010K842168ATAGO URINE SPECIFIC GRAVITY & SERUMK841713KYOTEST UG URINE TEST REAGENT STRIPK841714KYOTEST 2V, URINE TEST REAGENT STRIPK841715KYOTEST UK URINE TEST REAGENT STRIP

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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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