Cleared Traditional

HEMATOLOGY DATA MANAGEMENT SYS (K821534) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K821534 · Biovation, Inc. · Hematology device
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Jun 1982
Decision
17d
Days
Class 2
Risk

K821534 is an FDA 510(k) clearance for the HEMATOLOGY DATA MANAGEMENT SYS. Classified as Lowry (colorimetric), Total Protein (product code JGP), Class II - Special Controls.

Submitted by Biovation, Inc. (Walker, US). The FDA issued a Cleared decision on June 10, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1635 - 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 Biovation, Inc. devices

Submission Details

510(k) Number K821534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1982
Decision Date June 10, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 113d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGP Lowry (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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.