POINTE 750 GLYCOMETER— 510(k) K920449

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K920449 for POINTE 750 GLYCOMETER, Substantially Equivalent on 1992-07-28. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1992-02-02
Decision date: 1992-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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