OT IGG SORBENT— 510(k) K934324

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K934324 for OT IGG SORBENT, Substantially Equivalent on 1994-04-21. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code DEW
Advisory panel: Immunology
Date received: 1993-09-03
Decision date: 1994-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.