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FDA 510(k)

ORTHO-TOLUIDINE REAGENT SET

K-Number: K790319 · 1979-03-21

ApplicantFisher Scientific Co., LLC
Decision Date1979-03-21
Product CodeCGE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORTHO-TOLUIDINE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1979-03-21 under 510(k) number K790319. 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 ORTHO-TOLUIDINE REAGENT SET?

ORTHO-TOLUIDINE REAGENT SET is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K790319.

When did ORTHO-TOLUIDINE REAGENT SET receive FDA 510(k) clearance?

ORTHO-TOLUIDINE REAGENT SET received FDA 510(k) clearance on 1979-03-21, under 510(k) number K790319.

Who is the listed applicant for ORTHO-TOLUIDINE REAGENT SET?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO-TOLUIDINE REAGENT SET?

The FDA product code for ORTHO-TOLUIDINE REAGENT SET is CGE.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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