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FDA 510(k)

BUN/GLUCOSE STANDARDS

K-Number: K802633 · 1980-12-11

ApplicantGilford Diagnostics
Decision Date1980-12-11
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN/GLUCOSE STANDARDS is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802633. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUN/GLUCOSE STANDARDS?

BUN/GLUCOSE STANDARDS is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Gilford Diagnostics. The 510(k) number is K802633.

When did BUN/GLUCOSE STANDARDS receive FDA 510(k) clearance?

BUN/GLUCOSE STANDARDS received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802633.

Who is the listed applicant for BUN/GLUCOSE STANDARDS?

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

What is the FDA product code for BUN/GLUCOSE STANDARDS?

The FDA product code for BUN/GLUCOSE STANDARDS is JIX.

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Related Devices (Code: JIX)

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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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