SERUM TRANSPORT VIALS, T25/SC, TZ10/SC— 510(k) K851506

Substantially Equivalent

Ncs Diagnostics, Inc.

FDA 510(k) clearance K851506 for SERUM TRANSPORT VIALS, T25/SC, TZ10/SC, Substantially Equivalent on 1985-06-27. Applicant: Ncs Diagnostics, Inc..

Clearance details

Applicant: Ncs Diagnostics, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1985-04-15
Decision date: 1985-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, L4z 1y6, CA

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.