STAT K SYSTEM— 510(k) K915345

Name: FDA 510(k) clearance K915345
Creator: U.S. Food and Drug Administration
Published: 1992-07-16

Substantially Equivalent

Portable Diagnostic Services, Inc.

FDA 510(k) clearance K915345 for STAT K SYSTEM, Substantially Equivalent on 1992-07-16. Applicant: Portable Diagnostic Services, Inc.. Device class: 2.

Clearance details

Applicant: Portable Diagnostic Services, Inc.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1991-11-26
Decision date: 1992-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake Village, CA, US

Download summary PDF View on FDA.gov ↗

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