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FDA 510(k)

I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE

K-Number: K112430 · 2011-12-20

ApplicantAbbott Pont of Care, Inc.
Decision Date2011-12-20
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Pont of Care, Inc.. It received FDA 510(k) clearance on 2011-12-20 under 510(k) number K112430. 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 I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE?

I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE is a medical device that received FDA 510(k) clearance on 2011-12-20. The listed applicant is Abbott Pont of Care, Inc.. The 510(k) number is K112430.

When did I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE receive FDA 510(k) clearance?

I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE received FDA 510(k) clearance on 2011-12-20, under 510(k) number K112430.

Who is the listed applicant for I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE?

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

What is the FDA product code for I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE?

The FDA product code for I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE is KHP.

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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.

K130113PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare DiagnosticsK112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical CorporationK100602NOVA 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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