Cleared Traditional

K790776 - DADE LOW IONIC STRENGTH SOLUITION (LISS) (FDA 510(k) Clearance)

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

K790776 · Dade, Baxter Travenol Diagnostics, Inc. · Hematology device
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May 1979
Decision
33d
Days
Class 2
Risk

K790776 is an FDA 510(k) clearance for the DADE LOW IONIC STRENGTH SOLUITION (LISS). Classified as Media, Potentiating For In Vitro Diagnostic Use (product code KSG), Class II - Special Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1979 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9600 - 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 K790776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1979
Decision Date May 23, 1979
Days to Decision 33 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 113d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSG Media, Potentiating For In Vitro Diagnostic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9600
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.