WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000— 510(k) K982307

Name: FDA 510(k) clearance K982307
Creator: U.S. Food and Drug Administration
Published: 1999-02-02

Substantially Equivalent

Wallac, Inc.

FDA 510(k) clearance K982307 for WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000, Substantially Equivalent on 1999-02-02. Applicant: Wallac, Inc.. Device class: 2.

Clearance details

Applicant: Wallac, Inc.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 1998-07-01
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norton, OH, US

Download summary PDF View on FDA.gov ↗

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