FLO TEM (FLUID WARNER)— 510(k) K800699

Name: FDA 510(k) clearance K800699
Creator: U.S. Food and Drug Administration
Published: 1980-05-08

Substantially Equivalent

Chroma Products, Inc.

FDA 510(k) clearance K800699 for FLO TEM (FLUID WARNER), Substantially Equivalent on 1980-05-08. Applicant: Chroma Products, Inc.. Device class: 2.

Clearance details

Applicant: Chroma Products, Inc.
Product code: Code KZL
Device class: Class 2
Regulation: 21 CFR 864.9205
Advisory panel: Hematology
Date received: 1980-03-28
Decision date: 1980-05-08
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 KZL

product code KZL

Death: 3
Malfunction: 473
Total: 476

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.