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FDA 510(k)

YSI MODEL 1500 SPORT L-LACTATE ANALYZER

K-Number: K901131 · 1990-08-27

ApplicantYellow Springs Instrument Co., Inc.
Decision Date1990-08-27
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent for Some Indications

Device Summary

YSI MODEL 1500 SPORT L-LACTATE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Yellow Springs Instrument Co., Inc.. It received FDA 510(k) clearance on 1990-08-27 under 510(k) number K901131. The device is classified under product code KHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the YSI MODEL 1500 SPORT L-LACTATE ANALYZER?

YSI MODEL 1500 SPORT L-LACTATE ANALYZER is a medical device that received FDA 510(k) clearance on 1990-08-27. The listed applicant is Yellow Springs Instrument Co., Inc.. The 510(k) number is K901131.

When did YSI MODEL 1500 SPORT L-LACTATE ANALYZER receive FDA 510(k) clearance?

YSI MODEL 1500 SPORT L-LACTATE ANALYZER received FDA 510(k) clearance on 1990-08-27, under 510(k) number K901131.

Who is the listed applicant for YSI MODEL 1500 SPORT L-LACTATE ANALYZER?

The FDA 510(k) record lists Yellow Springs Instrument Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YSI MODEL 1500 SPORT L-LACTATE ANALYZER?

The FDA product code for YSI MODEL 1500 SPORT L-LACTATE ANALYZER is KHP.

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Other records listing Yellow Springs Instrument Co., 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.

K962070YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBEK922821YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBESK922007YSI MODEL 441A AIRWAY TEMPERATURE PROBEK910633YSI MODEL 1500 BLOOD GLUCOSE ANALYZERK910718YSI PRECISION 4000 THERMOMETERK893409YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP

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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

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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