COAT-A-COUNT INTACT PTH IRMA— 510(k) K930008

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K930008 for COAT-A-COUNT INTACT PTH IRMA, Substantially Equivalent on 1993-06-15. Applicant: Diagnostic Products Corp..

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1993-01-04
Decision date: 1993-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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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.