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FDA 510(k)

ATAGO URINE SPECIFIC GRAVITY & SERUM

K-Number: K842168 · 1984-07-16

ApplicantKyoto Diagnostics, Inc.
Decision Date1984-07-16
Product CodeJRE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAGO URINE SPECIFIC GRAVITY & SERUM 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 1984-07-16 under 510(k) number K842168. The device is classified under product code JRE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAGO URINE SPECIFIC GRAVITY & SERUM?

ATAGO URINE SPECIFIC GRAVITY & SERUM is a medical device that received FDA 510(k) clearance on 1984-07-16. The listed applicant is Kyoto Diagnostics, Inc.. The 510(k) number is K842168.

When did ATAGO URINE SPECIFIC GRAVITY & SERUM receive FDA 510(k) clearance?

ATAGO URINE SPECIFIC GRAVITY & SERUM received FDA 510(k) clearance on 1984-07-16, under 510(k) number K842168.

Who is the listed applicant for ATAGO URINE SPECIFIC GRAVITY & SERUM?

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 ATAGO URINE SPECIFIC GRAVITY & SERUM?

The FDA product code for ATAGO URINE SPECIFIC GRAVITY & SERUM is JRE.

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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-6010K841714KYOTEST 2V, URINE TEST REAGENT STRIPK841715KYOTEST UK URINE TEST REAGENT STRIPK841713KYOTEST UG URINE TEST REAGENT STRIP

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Related Devices (Code: JRE)

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.

K954977URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)Teco DiagnosticsK941906MODEL 2730 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941903MODEL 2740 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941901MODEL 2721 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941904MODEL A300CL CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941905MODEL 3461 CLINICAL REFRACTOMETERVee Gee Scientific, 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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