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FDA 510(k)

CARESIDE HDL-CHOLESTEROL

K-Number: K981899 · 1998-07-14

ApplicantExigent Diagnostics, Inc.
Decision Date1998-07-14
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE HDL-CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Exigent Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-07-14 under 510(k) number K981899. 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 CARESIDE HDL-CHOLESTEROL?

CARESIDE HDL-CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Exigent Diagnostics, Inc.. The 510(k) number is K981899.

When did CARESIDE HDL-CHOLESTEROL receive FDA 510(k) clearance?

CARESIDE HDL-CHOLESTEROL received FDA 510(k) clearance on 1998-07-14, under 510(k) number K981899.

Who is the listed applicant for CARESIDE HDL-CHOLESTEROL?

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

What is the FDA product code for CARESIDE HDL-CHOLESTEROL?

The FDA product code for CARESIDE HDL-CHOLESTEROL is LBS.

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Other records listing Exigent 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.

K982118CARESIDE ANALYZERK981183CARESIDE GLUCOSEK980043CARESIDE CREATININEK980056CARESIDE ANALYZERK980057CARESIDE BUNK980041CARESIDE ALBUMIN

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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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