BLOOD GROUPING SYS., BG-9— 510(k) K771098

Name: FDA 510(k) clearance K771098
Creator: U.S. Food and Drug Administration
Published: 1977-08-04

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K771098 for BLOOD GROUPING SYS., BG-9, Substantially Equivalent on 1977-08-04. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code KSZ
Device class: Class 2
Regulation: 21 CFR 864.9175
Advisory panel: Hematology
Date received: 1977-06-20
Decision date: 1977-08-04
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 KSZ

product code KSZ

Malfunction: 517
Total: 517

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.