Cleared Traditional

K945414 - RISTOCETIN COFACTOR ASSAY KIT

K945414 is the FDA 510(k) clearance for RISTOCETIN COFACTOR ASSAY KIT by Chrono-Log Corp.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K945414 · Chrono-Log Corp. · Hematology device
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Jan 1995
Decision
65d
Days
Class 2
Risk

K945414 is an FDA 510(k) clearance for the RISTOCETIN COFACTOR ASSAY KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on January 11, 1995 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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

Submission Details

510(k) Number K945414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date January 11, 1995
Days to Decision 65 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
48d faster than avg
Panel avg: 113d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 114
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K945414.
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