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FDA 510(k)

CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA

K-Number: K080623 · 2008-11-17

ApplicantJas Diagnostics, Inc.
Decision Date2008-11-17
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA is the device name listed in this FDA 510(k) record. The listed applicant is Jas Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-11-17 under 510(k) number K080623. 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 CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA?

CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA is a medical device that received FDA 510(k) clearance on 2008-11-17. The listed applicant is Jas Diagnostics, Inc.. The 510(k) number is K080623.

When did CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA receive FDA 510(k) clearance?

CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA received FDA 510(k) clearance on 2008-11-17, under 510(k) number K080623.

Who is the listed applicant for CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA?

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

What is the FDA product code for CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA?

The FDA product code for CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA is CHH.

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Other records listing Jas Diagnostics, Inc. as applicant

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Related Devices (Code: CHH)

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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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