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FDA 510(k)

CHOL OR CHOLESTEROL

K-Number: K971345 · 1997-05-29

ApplicantCarolina Liquid Chemistries Corp.
Decision Date1997-05-29
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOL OR CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corp.. It received FDA 510(k) clearance on 1997-05-29 under 510(k) number K971345. 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 CHOL OR CHOLESTEROL?

CHOL OR CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1997-05-29. The listed applicant is Carolina Liquid Chemistries Corp.. The 510(k) number is K971345.

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

CHOL OR CHOLESTEROL received FDA 510(k) clearance on 1997-05-29, under 510(k) number K971345.

Who is the listed applicant for CHOL OR CHOLESTEROL?

The FDA 510(k) record lists Carolina Liquid Chemistries Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOL OR CHOLESTEROL?

The FDA product code for CHOL OR CHOLESTEROL is CHH.

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Other records listing Carolina Liquid Chemistries Corp. 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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemK972073TOTAL BILIRUBIN REAGENTK971907CALCIUM REAGENTK971324TRIGLYCERIDES, TG, OR TRIGK971967BUNK971908CREA OR CREATININE

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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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