YSI MODEL 1500 SPORT L-LACTATE ANALYZER— 510(k) K901131

Name: FDA 510(k) clearance K901131
Creator: U.S. Food and Drug Administration
Published: 1990-08-27

Substantially Equivalent for Some Indications

Yellow Springs Instrument Co., Inc.

FDA 510(k) clearance K901131 for YSI MODEL 1500 SPORT L-LACTATE ANALYZER, Substantially Equivalent for Some Indications on 1990-08-27. Applicant: Yellow Springs Instrument Co., Inc.. Device class: 1.

Clearance details

Applicant: Yellow Springs Instrument Co., Inc.
Product code: Code KHP
Device class: Class 1
Regulation: 21 CFR 862.1450
Advisory panel: Clinical Chemistry
Date received: 1990-03-12
Decision date: 1990-08-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Yellow Springs, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.