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FDA 510(k)

PICCOLO TRIGLYCERIDES TEST SYSTEM

K-Number: K023639 · 2003-01-24

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

Device Summary

PICCOLO TRIGLYCERIDES 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 K023639. 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 PICCOLO TRIGLYCERIDES TEST SYSTEM?

PICCOLO TRIGLYCERIDES 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 K023639.

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

PICCOLO TRIGLYCERIDES TEST SYSTEM received FDA 510(k) clearance on 2003-01-24, under 510(k) number K023639.

Who is the listed applicant for PICCOLO TRIGLYCERIDES 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 TRIGLYCERIDES TEST SYSTEM?

The FDA product code for PICCOLO TRIGLYCERIDES TEST SYSTEM is JGY.

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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: 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.K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K971005TRIGLYCERIDESDerma Media Lab., Inc.K954187TRIGLYCERIDES REAGENTSchiapparelli Biosystems, Inc.K941063DNA TRIGLYCERIDE PROCEDUREData Medical Associates, 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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