SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)— 510(k) K902699

Name: FDA 510(k) clearance K902699
Creator: U.S. Food and Drug Administration
Published: 1990-07-16

Substantially Equivalent

Actio, Inc.

FDA 510(k) clearance K902699 for SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY), Substantially Equivalent on 1990-07-16. Applicant: Actio, Inc.. Device class: 1.

Clearance details

Applicant: Actio, Inc.
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1990-06-19
Decision date: 1990-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, 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.