IMX INSULIN— 510(k) K920109

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K920109 for IMX INSULIN, Substantially Equivalent on 1992-05-07. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CFP
Device class: Class 1
Regulation: 21 CFR 862.1405
Advisory panel: Clinical Chemistry
Date received: 1992-01-10
Decision date: 1992-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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K901135 — ENZYMUN TEST(R) INSULIN1990-04-03

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