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FDA 510(k)

GLUCOSE REAGENT (O-TOLUIDINE)

K-Number: K771314 · 1977-08-03

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

Device Summary

GLUCOSE REAGENT (O-TOLUIDINE) 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 K771314. The device is classified under product code CGE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE REAGENT (O-TOLUIDINE)?

GLUCOSE REAGENT (O-TOLUIDINE) 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 K771314.

When did GLUCOSE REAGENT (O-TOLUIDINE) receive FDA 510(k) clearance?

GLUCOSE REAGENT (O-TOLUIDINE) received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771314.

Who is the listed applicant for GLUCOSE REAGENT (O-TOLUIDINE)?

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 (O-TOLUIDINE)?

The FDA product code for GLUCOSE REAGENT (O-TOLUIDINE) is CGE.

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Other records listing Mallinckrodt Critical Care as applicant

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Related Devices (Code: CGE)

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.

K890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.Alpkem Corp.K855185GLUCOSE REAGENT SETTechnostics Intl.K850930GLUCOSEDilab, Inc.K841054DIRECT GLUCOSE REAGENT SETMedical Specialties, Inc.K821198DIRECT GLUCOSE REAGENT SETOmega Medical ElectronicsK811883KING DIAGNOSTICS GLUCOSE-O TESTKing Diagnostics, Inc.

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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