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FDA 510(k)

CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST

K-Number: K914033 · 1991-09-27

ApplicantCholestech Corp.
Decision Date1991-09-27
Product CodeJGY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST is the device name listed in this FDA 510(k) record. The listed applicant is Cholestech Corp.. It received FDA 510(k) clearance on 1991-09-27 under 510(k) number K914033. The device is classified under product code JGY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST?

CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is Cholestech Corp.. The 510(k) number is K914033.

When did CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST receive FDA 510(k) clearance?

CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST received FDA 510(k) clearance on 1991-09-27, under 510(k) number K914033.

Who is the listed applicant for CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST?

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 CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST?

The FDA product code for CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST is JGY.

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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

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Related Devices (Code: JGY)

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.

K120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMAbaxis, Inc.K023639PICCOLO TRIGLYCERIDES TEST SYSTEMAbaxis, Inc.K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K971005TRIGLYCERIDESDerma Media Lab., Inc.K954187TRIGLYCERIDES REAGENTSchiapparelli Biosystems, 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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