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FDA 510(k)

CHOLESTEROL (RATE) REAGENT

K-Number: K902098 · 1990-08-09

ApplicantSigma Chemical Co.
Decision Date1990-08-09
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL (RATE) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1990-08-09 under 510(k) number K902098. 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 CHOLESTEROL (RATE) REAGENT?

CHOLESTEROL (RATE) REAGENT is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is Sigma Chemical Co.. The 510(k) number is K902098.

When did CHOLESTEROL (RATE) REAGENT receive FDA 510(k) clearance?

CHOLESTEROL (RATE) REAGENT received FDA 510(k) clearance on 1990-08-09, under 510(k) number K902098.

Who is the listed applicant for CHOLESTEROL (RATE) REAGENT?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTEROL (RATE) REAGENT?

The FDA product code for CHOLESTEROL (RATE) REAGENT is CHH.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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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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