MONOSTICON UNI-DOT— 510(k) K853388

Substantially Equivalent

Organon, Inc.

FDA 510(k) clearance K853388 for MONOSTICON UNI-DOT, Substantially Equivalent on 1985-08-22. Applicant: Organon, Inc..

Clearance details

Applicant: Organon, Inc.
Product code: Code KTN
Advisory panel: Immunology
Date received: 1985-08-13
Decision date: 1985-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Orange, NJ, US

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