HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS— 510(k) K860336

Name: FDA 510(k) clearance K860336
Creator: U.S. Food and Drug Administration
Published: 1986-03-04

Substantially Equivalent

Breem Laboratories

FDA 510(k) clearance K860336 for HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS, Substantially Equivalent on 1986-03-04. Applicant: Breem Laboratories. Device class: 2.

Clearance details

Applicant: Breem Laboratories
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1986-01-29
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM1988-04-27
K873421 — KAWASUMI A.V. FISTULA SET1987-10-09
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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.