AQUEOUS BLOOD GAS CONTROL LEVEL I,II &— 510(k) K832003

Name: FDA 510(k) clearance K832003
Creator: U.S. Food and Drug Administration
Published: 1983-08-10

Substantially Equivalent

American Dade

FDA 510(k) clearance K832003 for AQUEOUS BLOOD GAS CONTROL LEVEL I,II &, Substantially Equivalent on 1983-08-10. Applicant: American Dade. Device class: 1.

Clearance details

Applicant: American Dade
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1983-06-22
Decision date: 1983-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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