Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TOTAL CHOLESTEROL CASSETTE

K-Number: K946064 · 1995-02-22

ApplicantCholestech Corp.
Decision Date1995-02-22
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL CHOLESTEROL CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Cholestech Corp.. It received FDA 510(k) clearance on 1995-02-22 under 510(k) number K946064. 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 TOTAL CHOLESTEROL CASSETTE?

TOTAL CHOLESTEROL CASSETTE is a medical device that received FDA 510(k) clearance on 1995-02-22. The listed applicant is Cholestech Corp.. The 510(k) number is K946064.

When did TOTAL CHOLESTEROL CASSETTE receive FDA 510(k) clearance?

TOTAL CHOLESTEROL CASSETTE received FDA 510(k) clearance on 1995-02-22, under 510(k) number K946064.

Who is the listed applicant for TOTAL CHOLESTEROL CASSETTE?

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

What is the FDA product code for TOTAL CHOLESTEROL CASSETTE?

The FDA product code for TOTAL CHOLESTEROL CASSETTE is CHH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cholestech 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.

K040579CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)K032027CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)K991834CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772K972012CHOLESTECH BUN/CREATININE TEST SYSTEMK954778CHOLESTECH LDX SYSTEMK946067TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL

View all 20 devices →

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.

↑