PROFIBLOT— 510(k) K933996

Name: FDA 510(k) clearance K933996
Creator: U.S. Food and Drug Administration
Published: 1994-01-28

Substantially Equivalent

Tecan U.S., Ltd.

FDA 510(k) clearance K933996 for PROFIBLOT, Substantially Equivalent on 1994-01-28. Applicant: Tecan U.S., Ltd.. Device class: 1.

Clearance details

Applicant: Tecan U.S., Ltd.
Product code: Code KPA
Device class: Class 1
Regulation: 21 CFR 864.3800
Advisory panel: Pathology
Date received: 1993-08-17
Decision date: 1994-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsborough, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPA

product code KPA

Malfunction: 1,177
Total: 1,177

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.