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FDA 510(k)

KYOTEST 5V

K-Number: K840827 · 1984-05-14

ApplicantKyoto Diagnostics, Inc.
Decision Date1984-05-14
Product CodeCEN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KYOTEST 5V 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 1984-05-14 under 510(k) number K840827. The device is classified under product code CEN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KYOTEST 5V?

KYOTEST 5V is a medical device that received FDA 510(k) clearance on 1984-05-14. The listed applicant is Kyoto Diagnostics, Inc.. The 510(k) number is K840827.

When did KYOTEST 5V receive FDA 510(k) clearance?

KYOTEST 5V received FDA 510(k) clearance on 1984-05-14, under 510(k) number K840827.

Who is the listed applicant for KYOTEST 5V?

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 KYOTEST 5V?

The FDA product code for KYOTEST 5V is CEN.

Related Clinical Trials

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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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.

K861733ADDITIONAL KYOTEST URINE TEST REAGENT STRIPSK843003GLUCOSE AUTO& STAT GA-1120K842750OSMOTIC PRESSURE AUTO & STAT OM-6010K842168ATAGO URINE SPECIFIC GRAVITY & SERUMK841714KYOTEST 2V, URINE TEST REAGENT STRIPK841715KYOTEST UK URINE TEST REAGENT STRIP

View all 11 devices →

Related Devices (Code: CEN)

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.

K091287VS-SENSE TESTCommon Sense , Ltd.K071100AMNISCREEN HOME DETECTION LINER KITCommon Sense , Ltd.K051727AIMSTICK URINE REAGENT STRIPSGermaine Laboratories, Inc.K040008QUICKVUE ADVANCE PH AND AMINES GLL TESTQuidel Corp.K030650STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONSUridynamics, Inc.K962718FEMEXAM TESTCARDLitmus Concepts, Inc.

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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