BLOOD GAS CONTROL PROD. NO. BG-1, BG-2— 510(k) K801449

Name: FDA 510(k) clearance K801449
Creator: U.S. Food and Drug Administration
Published: 1980-07-21

Substantially Equivalent

Health Diagnostics Corp.

FDA 510(k) clearance K801449 for BLOOD GAS CONTROL PROD. NO. BG-1, BG-2, Substantially Equivalent on 1980-07-21. Applicant: Health Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Health Diagnostics Corp.
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1980-06-23
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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