NATURALYTE BICARBONATE CONCENTRATE-DRY PACK— 510(k) K852310

Substantially Equivalent

Erika, Inc.

FDA 510(k) clearance K852310 for NATURALYTE BICARBONATE CONCENTRATE-DRY PACK, Substantially Equivalent on 1985-07-26. Applicant: Erika, Inc..

Clearance details

Applicant: Erika, Inc.
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-29
Decision date: 1985-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.