ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM— 510(k) K862189

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K862189 for ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM, Substantially Equivalent on 1986-09-08. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1986-06-09
Decision date: 1986-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kensington, TX, US

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Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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