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FDA 510(k)

BILIRUBIN CALIBRATORS & CONTROL

K-Number: K832094 · 1983-08-11

ApplicantGilford Diagnostics
Decision Date1983-08-11
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN CALIBRATORS & CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K832094. 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 & CONTROL?

BILIRUBIN CALIBRATORS & CONTROL is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is Gilford Diagnostics. The 510(k) number is K832094.

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

BILIRUBIN CALIBRATORS & CONTROL received FDA 510(k) clearance on 1983-08-11, under 510(k) number K832094.

Who is the listed applicant for BILIRUBIN CALIBRATORS & CONTROL?

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 & CONTROL?

The FDA product code for BILIRUBIN CALIBRATORS & CONTROL is JIT.

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Other records listing Gilford Diagnostics 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.

K831843GILCHEM TOTAL BILIRUBIN REAGENTK831844DIRECT BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORSK822289CO2/CI STANDARDS

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Related Devices (Code: JIT)

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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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