EMPTY SOLUTION TRANSFER CONTAINER— 510(k) K850035

Substantially Equivalent

The Healthcare Group Laboratories, Inc.

FDA 510(k) clearance K850035 for EMPTY SOLUTION TRANSFER CONTAINER, Substantially Equivalent on 1985-06-07. Applicant: The Healthcare Group Laboratories, Inc..

Clearance details

Applicant: The Healthcare Group Laboratories, Inc.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1985-01-07
Decision date: 1985-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orem, UT, US

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.