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FDA 510(k)

TDX REA CHOLESTEROL

K-Number: K842320 · 1984-08-15

ApplicantAbbott Laboratories
Decision Date1984-08-15
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TDX REA CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1984-08-15 under 510(k) number K842320. 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 TDX REA CHOLESTEROL?

TDX REA CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1984-08-15. The listed applicant is Abbott Laboratories. The 510(k) number is K842320.

When did TDX REA CHOLESTEROL receive FDA 510(k) clearance?

TDX REA CHOLESTEROL received FDA 510(k) clearance on 1984-08-15, under 510(k) number K842320.

Who is the listed applicant for TDX REA CHOLESTEROL?

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

What is the FDA product code for TDX REA CHOLESTEROL?

The FDA product code for TDX REA CHOLESTEROL is CHH.

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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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