DENLEY ANTHOS 2001 READER— 510(k) K894270

Name: FDA 510(k) clearance K894270
Creator: U.S. Food and Drug Administration
Published: 1989-08-21

Substantially Equivalent

Denley Instruments, Inc.

FDA 510(k) clearance K894270 for DENLEY ANTHOS 2001 READER, Substantially Equivalent on 1989-08-21. Applicant: Denley Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Denley Instruments, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1989-06-22
Decision date: 1989-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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