TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA— 510(k) K883720

Name: FDA 510(k) clearance K883720
Creator: U.S. Food and Drug Administration
Published: 1989-01-24

Substantially Equivalent

Lmd Laboratories

FDA 510(k) clearance K883720 for TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA, Substantially Equivalent on 1989-01-24. Applicant: Lmd Laboratories. Device class: 2.

Clearance details

Applicant: Lmd Laboratories
Product code: Code LGD
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1988-08-31
Decision date: 1989-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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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.