PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS— 510(k) K850333

Substantially Equivalent

Shaban Mfg. Co.

FDA 510(k) clearance K850333 for PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS, Substantially Equivalent on 1985-02-27. Applicant: Shaban Mfg. Co..

Clearance details

Applicant: Shaban Mfg. Co.
Product code: Code KPA
Advisory panel: Pathology
Date received: 1985-01-28
Decision date: 1985-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

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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.