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FDA 510(k)

FLUCOSE U.V. TEST KIT

K-Number: K770844 · 1977-07-14

ApplicantMallinckrodt Critical Care
Decision Date1977-07-14
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLUCOSE U.V. TEST KIT 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 1977-07-14 under 510(k) number K770844. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUCOSE U.V. TEST KIT?

FLUCOSE U.V. TEST KIT is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K770844.

When did FLUCOSE U.V. TEST KIT receive FDA 510(k) clearance?

FLUCOSE U.V. TEST KIT received FDA 510(k) clearance on 1977-07-14, under 510(k) number K770844.

Who is the listed applicant for FLUCOSE U.V. TEST KIT?

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 FLUCOSE U.V. TEST KIT?

The FDA product code for FLUCOSE U.V. TEST KIT is CFR.

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Other records listing Mallinckrodt Critical Care as applicant

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Related Devices (Code: CFR)

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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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