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FDA 510(k)

PICCOLO HDL TEST SYSTEM

K-Number: K023640 · 2003-01-24

ApplicantAbaxis, Inc.
Decision Date2003-01-24
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PICCOLO HDL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abaxis, Inc.. It received FDA 510(k) clearance on 2003-01-24 under 510(k) number K023640. 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 PICCOLO HDL TEST SYSTEM?

PICCOLO HDL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-24. The listed applicant is Abaxis, Inc.. The 510(k) number is K023640.

When did PICCOLO HDL TEST SYSTEM receive FDA 510(k) clearance?

PICCOLO HDL TEST SYSTEM received FDA 510(k) clearance on 2003-01-24, under 510(k) number K023640.

Who is the listed applicant for PICCOLO HDL TEST SYSTEM?

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

What is the FDA product code for PICCOLO HDL TEST SYSTEM?

The FDA product code for PICCOLO HDL TEST SYSTEM is LBS.

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Other records listing Abaxis, 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.

K200865Piccolo Potassium Test SystemK130113PICCOLO LACTATE TEST SYSTEMK130200PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEMK120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMK120662PICCOLO HDL-CAPILLARY TEST SYSTEMK091052PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM

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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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