IMX FOLATE— 510(k) K943691

Substantially Equivalent

Abbott Mfg., Inc.

FDA 510(k) clearance K943691 for IMX FOLATE, Substantially Equivalent on 1995-03-23. Applicant: Abbott Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Abbott Mfg., Inc.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1994-07-29
Decision date: 1995-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, 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.