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FDA 510(k)

JAS HDL CHOLESTEROL (AUTOMATED) REAGENT

K-Number: K021671 · 2002-07-19

ApplicantJas Diagnostics, Inc.
Decision Date2002-07-19
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

JAS HDL CHOLESTEROL (AUTOMATED) REAGENT 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 2002-07-19 under 510(k) number K021671. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAS HDL CHOLESTEROL (AUTOMATED) REAGENT?

JAS HDL CHOLESTEROL (AUTOMATED) REAGENT is a medical device that received FDA 510(k) clearance on 2002-07-19. The listed applicant is Jas Diagnostics, Inc.. The 510(k) number is K021671.

When did JAS HDL CHOLESTEROL (AUTOMATED) REAGENT receive FDA 510(k) clearance?

JAS HDL CHOLESTEROL (AUTOMATED) REAGENT received FDA 510(k) clearance on 2002-07-19, under 510(k) number K021671.

Who is the listed applicant for JAS HDL CHOLESTEROL (AUTOMATED) REAGENT?

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 JAS HDL CHOLESTEROL (AUTOMATED) REAGENT?

The FDA product code for JAS HDL CHOLESTEROL (AUTOMATED) REAGENT is LBS.

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Other records listing Jas Diagnostics, 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.

K080623CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NAK080618DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUIDK022519LDL CHOLESTEROL (AUTOMATED)K020454CHEMISTRY CALIBRATORK020282JAS AMYLASE LIQUID REAGENTK013912CREATINE KINASE (CK-NAC)

View all 19 devices →

Related Devices (Code: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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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