LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)— 510(k) K002536

Name: FDA 510(k) clearance K002536
Creator: U.S. Food and Drug Administration
Published: 2000-08-30

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K002536 for LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER), Substantially Equivalent on 2000-08-30. Applicant: Bio-Rad. Device class: 1.

Clearance details

Applicant: Bio-Rad
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2000-08-16
Decision date: 2000-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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