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FDA 510(k)

CHEMA CHOL CHOLESTEROL SYSTEM

K-Number: K904031 · 1991-03-11

ApplicantTexas Intl. Laboratories, Inc.
Decision Date1991-03-11
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMA CHOL CHOLESTEROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Texas Intl. Laboratories, Inc.. It received FDA 510(k) clearance on 1991-03-11 under 510(k) number K904031. 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 CHEMA CHOL CHOLESTEROL SYSTEM?

CHEMA CHOL CHOLESTEROL SYSTEM is a medical device that received FDA 510(k) clearance on 1991-03-11. The listed applicant is Texas Intl. Laboratories, Inc.. The 510(k) number is K904031.

When did CHEMA CHOL CHOLESTEROL SYSTEM receive FDA 510(k) clearance?

CHEMA CHOL CHOLESTEROL SYSTEM received FDA 510(k) clearance on 1991-03-11, under 510(k) number K904031.

Who is the listed applicant for CHEMA CHOL CHOLESTEROL SYSTEM?

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

What is the FDA product code for CHEMA CHOL CHOLESTEROL SYSTEM?

The FDA product code for CHEMA CHOL CHOLESTEROL SYSTEM is CHH.

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Other records listing Texas Intl. Laboratories, 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.

K953643HEMATIL 18 (H-18)K900685CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERK900684RDW AND MPV INDICES ON HEMAT 12K884006HEMAT 12K883177H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTERK853722PLT-4 PLATELET ANALYZER

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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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