MMH PTH RIA KIT— 510(k) K830700

Name: FDA 510(k) clearance K830700
Creator: U.S. Food and Drug Administration
Published: 1983-04-06

Substantially Equivalent

Diagnostic Systems

FDA 510(k) clearance K830700 for MMH PTH RIA KIT, Substantially Equivalent on 1983-04-06. Applicant: Diagnostic Systems. Device class: 2.

Clearance details

Applicant: Diagnostic Systems
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 1983-03-07
Decision date: 1983-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.