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FDA 510(k)

DIGITOXIN FPIA REAGENT SET

K-Number: K915465 · 1992-01-27

ApplicantSigma Diagnostics, Inc.
Decision Date1992-01-27
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGITOXIN FPIA REAGENT SET 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 1992-01-27 under 510(k) number K915465. The device is classified under product code LFM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITOXIN FPIA REAGENT SET?

DIGITOXIN FPIA REAGENT SET is a medical device that received FDA 510(k) clearance on 1992-01-27. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K915465.

When did DIGITOXIN FPIA REAGENT SET receive FDA 510(k) clearance?

DIGITOXIN FPIA REAGENT SET received FDA 510(k) clearance on 1992-01-27, under 510(k) number K915465.

Who is the listed applicant for DIGITOXIN FPIA REAGENT SET?

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 DIGITOXIN FPIA REAGENT SET?

The FDA product code for DIGITOXIN FPIA REAGENT SET is LFM.

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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: LFM)

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.

K062024DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGEDade Behring, Inc.K012112RANDOX DIGITOXINRandox Laboratories, Ltd.K990251DGTX FLEX REAGENT CARTRIDGE, MODEL DF36Dade Behring, Inc.K970546ACS DIGITOXINChiron Diagnostics Corp.K963158ABBOTT AXSYM DIGITOXIN (MODIFY)Abbott LaboratoriesK954420AXSYM DIGITOXINAbbott Laboratories

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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