WASHER 500 MICROELISA SYSTEM— 510(k) K884695

Name: FDA 510(k) clearance K884695
Creator: U.S. Food and Drug Administration
Published: 1988-12-13

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K884695 for WASHER 500 MICROELISA SYSTEM, Substantially Equivalent on 1988-12-13. Applicant: Organon Teknika Corp.. Device class: 1.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JTC
Device class: Class 1
Regulation: 21 CFR 866.2500
Advisory panel: Microbiology
Date received: 1988-11-09
Decision date: 1988-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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.