Cleared Traditional

K820396 - AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR

K820396 is the FDA 510(k) clearance for AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR by Pheragen Technology Corp.. It is a Class 2 Hematology device (product code GKT) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K820396 · Pheragen Technology Corp. · Hematology device
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Apr 1982
Decision
75d
Days
Class 2
Risk

K820396 is an FDA 510(k) clearance for the AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR. Classified as Separator, Automated, Blood Cell, Diagnostic (product code GKT), Class II - Special Controls.

Submitted by Pheragen Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1982 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9245 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pheragen Technology Corp. devices

Submission Details

510(k) Number K820396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1982
Decision Date April 27, 1982
Days to Decision 75 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 113d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKT Separator, Automated, Blood Cell, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9245
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.