YSI MODELS 23C & 23CM HDL & TOTAL CHOLES— 510(k) K801285

Name: FDA 510(k) clearance K801285
Creator: U.S. Food and Drug Administration
Published: 1980-07-28

Substantially Equivalent

Yellow Springs Instrument Co., Inc.

FDA 510(k) clearance K801285 for YSI MODELS 23C & 23CM HDL & TOTAL CHOLES, Substantially Equivalent on 1980-07-28. Applicant: Yellow Springs Instrument Co., Inc.. Device class: 1.

Clearance details

Applicant: Yellow Springs Instrument Co., Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1980-05-29
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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