FDA 510(k)

BILIRUBIN CALIBRATORS

K-Number: K822334 · 1982-09-02

Decision Date1982-09-02

Product CodeJIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BILIRUBIN CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1982-09-02 under 510(k) number K822334. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILIRUBIN CALIBRATORS?

BILIRUBIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 1982-09-02. The listed applicant is Gilford Diagnostics. The 510(k) number is K822334.

When did BILIRUBIN CALIBRATORS receive FDA 510(k) clearance?

BILIRUBIN CALIBRATORS received FDA 510(k) clearance on 1982-09-02, under 510(k) number K822334.

Who is the listed applicant for BILIRUBIN CALIBRATORS?

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 BILIRUBIN CALIBRATORS?

The FDA product code for BILIRUBIN CALIBRATORS is JIT.

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Other records listing Gilford Diagnostics as applicant

K832094BILIRUBIN CALIBRATORS & CONTROL K831844DIRECT BILIRUBIN REAGENT K831843GILCHEM TOTAL BILIRUBIN REAGENT K823709TRIGLYCERIDE REAGENT (UV)K822739AHBD K822289CO2/CI STANDARDS

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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.