AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR— 510(k) K820396

Name: FDA 510(k) clearance K820396
Creator: U.S. Food and Drug Administration
Published: 1982-04-27

Substantially Equivalent

Pheragen Technology Corp.

FDA 510(k) clearance K820396 for AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR, Substantially Equivalent on 1982-04-27. Applicant: Pheragen Technology Corp.. Device class: 2.

Clearance details

Applicant: Pheragen Technology Corp.
Product code: Code GKT
Device class: Class 2
Regulation: 21 CFR 864.9245
Advisory panel: Hematology
Date received: 1982-02-11
Decision date: 1982-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKT

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K200530 — AMICUS Separator System2020-09-11
K162462 — AMICUS Separator System, AMICUS Separator System; Refurbished2016-11-23
K822521 — AUTOMATED BLOOD CELL SEPARATOR1982-09-30
K801233 — CELLTRIFUGE II1980-10-31
K791106 — STERILE, DISPOSABLE CENTRIFUGE BOWL1979-08-10

Adverse events under product code GKT

product code GKT

Death: 167
Injury: 301
Malfunction: 2,086
Total: 2,554

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.