REPLIANALYZER— 510(k) K861958

Substantially Equivalent

Mct Medical, Inc.

FDA 510(k) clearance K861958 for REPLIANALYZER, Substantially Equivalent on 1986-08-01. Applicant: Mct Medical, Inc..

Clearance details

Applicant: Mct Medical, Inc.
Product code: Code LON
Advisory panel: Microbiology
Date received: 1986-05-20
Decision date: 1986-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code LON

product code LON

Malfunction: 2,383
Total: 2,383

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.