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FDA 510(k)

LACTATE PRO SYSTEM

K-Number: K980908 · 1998-09-11

ApplicantKdk Corp.
Decision Date1998-09-11
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTATE PRO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kdk Corp.. It received FDA 510(k) clearance on 1998-09-11 under 510(k) number K980908. 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 LACTATE PRO SYSTEM?

LACTATE PRO SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-11. The listed applicant is Kdk Corp.. The 510(k) number is K980908.

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

LACTATE PRO SYSTEM received FDA 510(k) clearance on 1998-09-11, under 510(k) number K980908.

Who is the listed applicant for LACTATE PRO SYSTEM?

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

What is the FDA product code for LACTATE PRO SYSTEM?

The FDA product code for LACTATE PRO SYSTEM 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 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.

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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