WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3— 510(k) K800296

Name: FDA 510(k) clearance K800296
Creator: U.S. Food and Drug Administration
Published: 1980-03-05

Substantially Equivalent

Dade, Baxter Travenol Diagnostics, Inc.

FDA 510(k) clearance K800296 for WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3, Substantially Equivalent on 1980-03-05. Applicant: Dade, Baxter Travenol Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Dade, Baxter Travenol Diagnostics, Inc.
Product code: Code GGM
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1980-02-11
Decision date: 1980-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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