OREIA-Q-TY, ENZYME IMMUNOASSAY— 510(k) K802693

Substantially Equivalent

Organon, Inc.

FDA 510(k) clearance K802693 for OREIA-Q-TY, ENZYME IMMUNOASSAY, Substantially Equivalent on 1980-12-10. Applicant: Organon, Inc..

Clearance details

Applicant: Organon, Inc.
Product code: Code KLI
Advisory panel: Clinical Chemistry
Date received: 1980-10-30
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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