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FDA 510(k)

PICCOLO LACTATE TEST SYSTEM

K-Number: K130113 · 2013-03-11

ApplicantAbaxis, Inc.
Decision Date2013-03-11
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PICCOLO LACTATE 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 2013-03-11 under 510(k) number K130113. The device is classified under product code KHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICCOLO LACTATE TEST SYSTEM?

PICCOLO LACTATE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-11. The listed applicant is Abaxis, Inc.. The 510(k) number is K130113.

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

PICCOLO LACTATE TEST SYSTEM received FDA 510(k) clearance on 2013-03-11, under 510(k) number K130113.

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

The FDA product code for PICCOLO LACTATE TEST SYSTEM is KHP.

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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 SystemK130200PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEMK120662PICCOLO HDL-CAPILLARY TEST SYSTEMK120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMK091052PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEMK091910PICCOLO MAGNESIUM TEST SYSTEM

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Related Devices (Code: KHP)

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.

K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare DiagnosticsK112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical CorporationK112430I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSNova Biomedical Corp.K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEEpocal, Inc.K013938IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGEDiametrics Medical, 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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