Cleared Traditional

K940792 - AGGRO/LINK VW COFACTOR SOFTWARE

K940792 is the FDA 510(k) clearance for AGGRO/LINK VW COFACTOR SOFTWARE by Chrono-Log Corp.. It is a Class 2 Hematology device (product code JOZ) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K940792 · Chrono-Log Corp. · Hematology device
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Oct 1994
Decision
233d
Days
Class 2
Risk

K940792 is an FDA 510(k) clearance for the AGGRO/LINK VW COFACTOR SOFTWARE. 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 October 13, 1994 after a review of 233 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chrono-Log Corp. devices

Submission Details

510(k) Number K940792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date October 13, 1994
Days to Decision 233 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 113d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K940792.
PLATELETWORKS, MODELS PW-A, PW-C
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K800432 · Helena Laboratories · Mar 1980