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FDA 510(k)

SPECIFIC GRAVITY INSTRUMENT

K-Number: K831213 · 1983-06-30

ApplicantIris
Decision Date1983-06-30
Product CodeJRE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECIFIC GRAVITY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Iris. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831213. 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 SPECIFIC GRAVITY INSTRUMENT?

SPECIFIC GRAVITY INSTRUMENT is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Iris. The 510(k) number is K831213.

When did SPECIFIC GRAVITY INSTRUMENT receive FDA 510(k) clearance?

SPECIFIC GRAVITY INSTRUMENT received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831213.

Who is the listed applicant for SPECIFIC GRAVITY INSTRUMENT?

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

What is the FDA product code for SPECIFIC GRAVITY INSTRUMENT?

The FDA product code for SPECIFIC GRAVITY INSTRUMENT is JRE.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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