CRIT-LINE BLOOD CHAMBER WITH E-BEAM— 510(k) K935958

Substantially Equivalent

In-Line Diagnostics Corp.

FDA 510(k) clearance K935958 for CRIT-LINE BLOOD CHAMBER WITH E-BEAM, Substantially Equivalent on 1995-01-19. Applicant: In-Line Diagnostics Corp..

Clearance details

Applicant: In-Line Diagnostics Corp.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1993-11-26
Decision date: 1995-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverdale, UT, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.