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FDA 510(k)

TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR

K-Number: K944371 · 1994-11-10

ApplicantSigma Diagnostics, Inc.
Decision Date1994-11-10
Product CodeLFW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-11-10 under 510(k) number K944371. The device is classified under product code LFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR?

TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K944371.

When did TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR receive FDA 510(k) clearance?

TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR received FDA 510(k) clearance on 1994-11-10, under 510(k) number K944371.

Who is the listed applicant for TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR?

The FDA 510(k) record lists Sigma Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR?

The FDA product code for TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR is LFW.

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Other records listing Sigma Diagnostics, Inc. 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

View all 164 devices →

Related Devices (Code: LFW)

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.

K964670ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINRoche Diagnostic Systems, Inc.K941614AXSYM TOBRAMYCINAbbott LaboratoriesK912143CEDIA(R) TOBRAMYCIN ASSAYMicrogenics Corp.K900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORInnotron of Oregon, Inc.K894531FPR TOBRAMYCIN KITColony Laboratories, Inc.K872562INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SETInnotron of Oregon, 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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