SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX— 510(k) K960072

Name: FDA 510(k) clearance K960072
Creator: U.S. Food and Drug Administration
Published: 1997-03-06

Substantially Equivalent

Biochem Immunosystems (U.S.), Inc.

FDA 510(k) clearance K960072 for SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX, Substantially Equivalent on 1997-03-06. Applicant: Biochem Immunosystems (U.S.), Inc.. Device class: 2.

Clearance details

Applicant: Biochem Immunosystems (U.S.), Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1996-01-05
Decision date: 1997-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

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.