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FDA 510(k)

FACTOR

K-Number: K935058 · 1994-03-07

ApplicantSigma Diagnostics, Inc.
Decision Date1994-03-07
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACTOR 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 1994-03-07 under 510(k) number K935058. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACTOR?

FACTOR is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K935058.

When did FACTOR receive FDA 510(k) clearance?

FACTOR received FDA 510(k) clearance on 1994-03-07, under 510(k) number K935058.

Who is the listed applicant for FACTOR?

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 FACTOR?

The FDA product code for FACTOR is GJT.

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Related PubMed Literature

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.

PMID: 41483527Systematic review of usability evaluations in medical devices: Methodological choices, heuristic application, and confounding factors.Applied ergonomics ()PMID: 35106697Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care.3D printing in medicine ()

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: GJT)

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.

K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory COK102851NOFACT VIIIR2 Diagnostics, Inc.K102908NOFACT IXR2 Diagnostics, Inc.K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory COK050661HEMOSIL FACTOR II DEFICIENT PLASMAInstrumentation Laboratory CO

Official Source

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