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FDA 510(k)

GLUCOSE REAGENT (HEXOHINASE)

K-Number: K771311 · 1977-08-03

ApplicantMallinckrodt Critical Care
Decision Date1977-08-03
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE REAGENT (HEXOHINASE) 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 1977-08-03 under 510(k) number K771311. 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 GLUCOSE REAGENT (HEXOHINASE)?

GLUCOSE REAGENT (HEXOHINASE) is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K771311.

When did GLUCOSE REAGENT (HEXOHINASE) receive FDA 510(k) clearance?

GLUCOSE REAGENT (HEXOHINASE) received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771311.

Who is the listed applicant for GLUCOSE REAGENT (HEXOHINASE)?

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 GLUCOSE REAGENT (HEXOHINASE)?

The FDA product code for GLUCOSE REAGENT (HEXOHINASE) is CFR.

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Other records listing Mallinckrodt Critical Care as applicant

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Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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