FDA 510(k)

CREATININE STANDARDS

K-Number: K802631 · 1980-12-11

Decision Date1980-12-11

Product CodeJIS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CREATININE 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 K802631. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATININE STANDARDS?

CREATININE 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 K802631.

When did CREATININE STANDARDS receive FDA 510(k) clearance?

CREATININE STANDARDS received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802631.

Who is the listed applicant for CREATININE 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 CREATININE STANDARDS?

The FDA product code for CREATININE STANDARDS is JIS.

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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.