IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6— 510(k) K012075

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K012075 for IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6, Substantially Equivalent on 2002-01-10. Applicant: Diagnostic Products Corp..

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 2001-07-02
Decision date: 2002-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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.