REPLIANALYZER— 510(k) K861958
Substantially EquivalentMct Medical, Inc.
FDA 510(k) clearance K861958 for REPLIANALYZER, Substantially Equivalent on 1986-08-01. Applicant: Mct Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Mct Medical, Inc.
- Product code
- Code LON
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
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More clearances from Mct Medical, Inc.
view allAdverse events under product code LON
product code LON- Malfunction
- 2,383
- Total
- 2,383
Source: openFDA MAUDE database, through . 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.