COULTER COUNTER MODEL S-PLUS V— 510(k) K833600

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K833600 for COULTER COUNTER MODEL S-PLUS V, Substantially Equivalent on 1984-01-10. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1983-10-12
Decision date: 1984-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.