N-TACT(R) PTH SP KIT— 510(k) K921629

Name: FDA 510(k) clearance K921629
Creator: U.S. Food and Drug Administration
Published: 1992-05-14

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K921629 for N-TACT(R) PTH SP KIT, Substantially Equivalent on 1992-05-14. Applicant: Incstar Corp.. Device class: 2.

Clearance details

Applicant: Incstar Corp.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 1992-04-06
Decision date: 1992-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, 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.