Cleared Traditional

K792563 - THROMBOKINETIC FIBRINOGEN ASSAY

K792563 is the FDA 510(k) clearance for THROMBOKINETIC FIBRINOGEN ASSAY by Bio/Data Corp.. It is a Class 2 Hematology device (product code KQJ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K792563 · Bio/Data Corp. · Hematology device
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Jan 1980
Decision
30d
Days
Class 2
Risk

K792563 is an FDA 510(k) clearance for the THROMBOKINETIC FIBRINOGEN ASSAY. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - 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 Bio/Data Corp. devices

Submission Details

510(k) Number K792563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1979
Decision Date January 11, 1980
Days to Decision 30 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KQJ System, Fibrinogen Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
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.