Cleared Traditional

K780047 - PLATELET AGGREGATING REAGENTS

K780047 is an FDA 510(k) clearance for PLATELET AGGREGATING REAGENTS, manufactured by Dade, Baxter Travenol Diagnostics, Inc.. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K780047 · Dade, Baxter Travenol Diagnostics, Inc. · Hematology device
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Mar 1978
Decision
52d
Days
Class 2
Risk

K780047 is an FDA 510(k) clearance for the PLATELET AGGREGATING REAGENTS. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1978 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - 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.

FDA 510(k) Submission Details - K780047

510(k) Number K780047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1978
Decision Date March 02, 1978
Days to Decision 52 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 113d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOZ Device Classification - Class 2, Special Controls

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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.

Regulatory Peers - JOZ System, Automated Platelet Aggregation

All 37
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K780047.
COLLAGENREAGENT HORM
K781693 · Hormon-Chemie Munchem Gmch · Dec 1978
REAGENT, FIREFLY #395
K781807 · Chrono-Log Corp. · Nov 1978
SOLUBLE COLLAGEN
K780285 · General Diagnostics · Mar 1978
THROMBO-CETIN (RISTOCETIN)
K770395 · Bay Area Hema. Onco. Clinic. & Res. L · Mar 1977
AGGRECETIN
K760893 · Bio/Data Corp. · Jan 1977
K780047 · PLATELET AGGREGATING REAGENTS
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