IMMUNLITE INTACT PTH— 510(k) K934760

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K934760 for IMMUNLITE INTACT PTH, Substantially Equivalent on 1993-12-10. Applicant: Diagnostic Products Corp..

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1993-10-04
Decision date: 1993-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.