IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST— 510(k) K121231

Substantially Equivalent

Ind Ndiagnostic, Inc.

FDA 510(k) clearance K121231 for IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST, Substantially Equivalent on 2012-07-30. Applicant: Ind Ndiagnostic, Inc..

Clearance details

Applicant: Ind Ndiagnostic, Inc.
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2012-04-24
Decision date: 2012-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delta, B.C., CA

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Adverse events under product code NGT

product code NGT

Death: 12
Malfunction: 2,008
Other: 4
Total: 2,024

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.