IMX(R) GLYCATED HEMOGLOBIN— 510(k) K921831

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K921831 for IMX(R) GLYCATED HEMOGLOBIN, Substantially Equivalent on 1992-09-29. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1992-04-16
Decision date: 1992-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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