Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM

K-Number: K120664 · 2012-04-24

ApplicantAbaxis, Inc.
Decision Date2012-04-24
Product CodeJGY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PICCOLO TRGLYCERIDES-CAPILLARY 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 2012-04-24 under 510(k) number K120664. 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 TRGLYCERIDES-CAPILLARY TEST SYSTEM?

PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-24. The listed applicant is Abaxis, Inc.. The 510(k) number is K120664.

When did PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM receive FDA 510(k) clearance?

PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM received FDA 510(k) clearance on 2012-04-24, under 510(k) number K120664.

Who is the listed applicant for PICCOLO TRGLYCERIDES-CAPILLARY 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 TRGLYCERIDES-CAPILLARY TEST SYSTEM?

The FDA product code for PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM is JGY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK120662PICCOLO HDL-CAPILLARY TEST SYSTEMK091052PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEMK091910PICCOLO MAGNESIUM TEST SYSTEM

View all 20 devices →

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.

K023639PICCOLO TRIGLYCERIDES 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.

↑