Cleared Traditional

K781807 - REAGENT, FIREFLY #395

K781807 is an FDA 510(k) clearance for REAGENT, manufactured by Chrono-Log Corp.. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K781807 · Chrono-Log Corp. · Hematology device
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Nov 1978
Decision
28d
Days
Class 2
Risk

K781807 is an FDA 510(k) clearance for the REAGENT, FIREFLY #395. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 28 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.

View all Chrono-Log Corp. devices

FDA 510(k) Submission Details - K781807

510(k) Number K781807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1978
Decision Date November 22, 1978
Days to Decision 28 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 113d · This submission: 28d
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 20
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K781807.
PLATELET AGGREGATION REAGENTS
K800146 · Pacific Hemostasis · Feb 1980
ELVI 840 AGGREGOMETER
K791577 · Volu Sol Medical Industries · Sep 1979
BETA/PAK
K790769 · Bio/Data Corp. · May 1979
SOLUBLE COLLAGEN
K780285 · General Diagnostics · Mar 1978
PLATELET AGGREGATING REAGENTS
K780047 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1978
AGGRECETIN
K760893 · Bio/Data Corp. · Jan 1977