LXN FRUCTOSAMINE TEST SYSTEM— 510(k) K962597

Substantially Equivalent

Lxn Corp.

FDA 510(k) clearance K962597 for LXN FRUCTOSAMINE TEST SYSTEM, Substantially Equivalent on 1997-06-13. Applicant: Lxn Corp.. Device class: 2.

Clearance details

Applicant: Lxn Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1996-07-02
Decision date: 1997-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.