PLATELIN(R) EXCEL L— 510(k) K881999

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K881999 for PLATELIN(R) EXCEL L, Substantially Equivalent on 1988-08-17. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code GIT
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1988-05-12
Decision date: 1988-08-17
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.