ACCUWELL PHENYLALANINE ASSAY— 510(k) K974047

Substantially Equivalent

Neometrics, Inc.

FDA 510(k) clearance K974047 for ACCUWELL PHENYLALANINE ASSAY, Substantially Equivalent on 1997-12-05. Applicant: Neometrics, Inc.. Device class: 2.

Clearance details

Applicant: Neometrics, Inc.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 1997-10-24
Decision date: 1997-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: E. Northport, NY, 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.