BLOOD GLUCOSE TESTER— 510(k) K801536

Substantially Equivalent

Broomer Research Corp.

FDA 510(k) clearance K801536 for BLOOD GLUCOSE TESTER, Substantially Equivalent on 1980-09-16. Applicant: Broomer Research Corp.. Device class: 1.

Clearance details

Applicant: Broomer Research Corp.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1980-07-03
Decision date: 1980-09-16
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.