ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER— 510(k) K990507

Substantially Equivalent

Althin Biopharm, Inc.

FDA 510(k) clearance K990507 for ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER, Substantially Equivalent on 1999-05-07. Applicant: Althin Biopharm, Inc..

Clearance details

Applicant: Althin Biopharm, Inc.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1999-02-18
Decision date: 1999-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval, Quebec, CA

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Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.