MICROELISA COMP— 510(k) K831658

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K831658 for MICROELISA COMP, Substantially Equivalent on 1983-07-26. Applicant: Organon Teknika Corp.. Device class: 1.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code LIB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1983-05-23
Decision date: 1983-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.