Cleared Traditional

K782098 - REAGENT, LYSING AND HEMOGLOBIN (FDA 510(k) Clearance)

Class I Hematology device.

K782098 · Dade, Baxter Travenol Diagnostics, Inc. · Hematology device
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Jan 1979
Decision
30d
Days
Class 1
Risk

K782098 is an FDA 510(k) clearance for the REAGENT, LYSING AND HEMOGLOBIN. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8540 - 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 Dade, Baxter Travenol Diagnostics, Inc. devices

Submission Details

510(k) Number K782098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1978
Decision Date January 17, 1979
Days to Decision 30 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GGK Products, Red-cell Lysing Products
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.