AQUEOUS BLOOD GAS CONTROL— 510(k) K833146

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K833146 for AQUEOUS BLOOD GAS CONTROL, Substantially Equivalent on 1983-11-28. Applicant: Bionostics, Inc.. Device class: 1.

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1983-09-15
Decision date: 1983-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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