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FDA 510(k)

NIKON URINE REFRACTOMER SG-1

K-Number: K802959 · 1980-12-19

ApplicantNippon Kogaku, Inc.
Decision Date1980-12-19
Product CodeJRE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NIKON URINE REFRACTOMER SG-1 is the device name listed in this FDA 510(k) record. The listed applicant is Nippon Kogaku, Inc.. It received FDA 510(k) clearance on 1980-12-19 under 510(k) number K802959. 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 NIKON URINE REFRACTOMER SG-1?

NIKON URINE REFRACTOMER SG-1 is a medical device that received FDA 510(k) clearance on 1980-12-19. The listed applicant is Nippon Kogaku, Inc.. The 510(k) number is K802959.

When did NIKON URINE REFRACTOMER SG-1 receive FDA 510(k) clearance?

NIKON URINE REFRACTOMER SG-1 received FDA 510(k) clearance on 1980-12-19, under 510(k) number K802959.

Who is the listed applicant for NIKON URINE REFRACTOMER SG-1?

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

What is the FDA product code for NIKON URINE REFRACTOMER SG-1?

The FDA product code for NIKON URINE REFRACTOMER SG-1 is JRE.

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 Nippon Kogaku, 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.

K802958AUTO REFRACTOMETER NR-1000

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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