HCG-NOSTICK— 510(k) K880328

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K880328 for HCG-NOSTICK, Substantially Equivalent on 1988-03-15. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1988-01-26
Decision date: 1988-03-15
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.