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FDA 510(k)

COMBINED GLUCOSE AND BUN STANDARDS

K-Number: K802825 · 1980-12-11

ApplicantMallinckrodt Critical Care
Decision Date1980-12-11
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COMBINED GLUCOSE AND BUN STANDARDS is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802825. 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 COMBINED GLUCOSE AND BUN STANDARDS?

COMBINED GLUCOSE AND BUN STANDARDS is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K802825.

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

COMBINED GLUCOSE AND BUN STANDARDS received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802825.

Who is the listed applicant for COMBINED GLUCOSE AND BUN STANDARDS?

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

What is the FDA product code for COMBINED GLUCOSE AND BUN STANDARDS?

The FDA product code for COMBINED GLUCOSE AND BUN 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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