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FDA 510(k)

SIGMA PROCEDURE NO. 333-UV

K-Number: K914777 · 1991-12-27

ApplicantSigma Diagnostics, Inc.
Decision Date1991-12-27
Product CodeDML
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SIGMA PROCEDURE NO. 333-UV 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 1991-12-27 under 510(k) number K914777. The device is classified under product code DML. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA PROCEDURE NO. 333-UV?

SIGMA PROCEDURE NO. 333-UV is a medical device that received FDA 510(k) clearance on 1991-12-27. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K914777.

When did SIGMA PROCEDURE NO. 333-UV receive FDA 510(k) clearance?

SIGMA PROCEDURE NO. 333-UV received FDA 510(k) clearance on 1991-12-27, under 510(k) number K914777.

Who is the listed applicant for SIGMA PROCEDURE NO. 333-UV?

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 SIGMA PROCEDURE NO. 333-UV?

The FDA product code for SIGMA PROCEDURE NO. 333-UV is DML.

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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: DML)

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.

K013538ETHANOLAbbott LaboratoriesK993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409ULSyva Co.K963197ON.SITE ALCOHOLAnsys, Inc.K953765AXSYM REA ETHANOLAbbott LaboratoriesK952839BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAYBoehringer Mannheim Corp.K923337ON*SITE ALCOHOLToxi-Lab, 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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