PROTEIN-BASED BLOOD GAS CONTROL— 510(k) K812541

Substantially Equivalent

American Dade

FDA 510(k) clearance K812541 for PROTEIN-BASED BLOOD GAS CONTROL, Substantially Equivalent on 1981-09-23. 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: 1981-09-04
Decision date: 1981-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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