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FDA 510(k)

GENTAMICIN FPIA REAGENT SET AND CALIBRATORS

K-Number: K943550 · 1994-11-17

ApplicantSigma Diagnostics, Inc.
Decision Date1994-11-17
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN FPIA REAGENT SET AND CALIBRATORS 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 1994-11-17 under 510(k) number K943550. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN FPIA REAGENT SET AND CALIBRATORS?

GENTAMICIN FPIA REAGENT SET AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K943550.

When did GENTAMICIN FPIA REAGENT SET AND CALIBRATORS receive FDA 510(k) clearance?

GENTAMICIN FPIA REAGENT SET AND CALIBRATORS received FDA 510(k) clearance on 1994-11-17, under 510(k) number K943550.

Who is the listed applicant for GENTAMICIN FPIA REAGENT SET AND CALIBRATORS?

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 GENTAMICIN FPIA REAGENT SET AND CALIBRATORS?

The FDA product code for GENTAMICIN FPIA REAGENT SET AND CALIBRATORS is LCQ.

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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

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Related Devices (Code: LCQ)

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.

K972609VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAMBio-RadK955569INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.K905721OPUS GENTAMICINPb Diagnostic Systems, Inc.K904226'TDXFLX ANALYZERAbbott LaboratoriesK894523FPR GENTAMICIN KITColony Laboratories, 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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