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FDA 510(k)

INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)

K-Number: K980667 · 1998-04-21

ApplicantSigma Diagnostics, Inc.
Decision Date1998-04-21
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) 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 1998-04-21 under 510(k) number K980667. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)?

INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K980667.

When did INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) receive FDA 510(k) clearance?

INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) received FDA 510(k) clearance on 1998-04-21, under 510(k) number K980667.

Who is the listed applicant for INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)?

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 INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)?

The FDA product code for INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) is CHH.

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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: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON 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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