DIALYSATE CONCENTRATE— 510(k) K812330

Name: FDA 510(k) clearance K812330
Creator: U.S. Food and Drug Administration
Published: 1981-09-29

Substantially Equivalent

Central Biological Co.

FDA 510(k) clearance K812330 for DIALYSATE CONCENTRATE, Substantially Equivalent on 1981-09-29. Applicant: Central Biological Co.. Device class: 2.

Clearance details

Applicant: Central Biological Co.
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1981-08-18
Decision date: 1981-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.