Cleared Traditional

K813404 - FREEZE DRIED FICIN

K813404 is an FDA 510(k) clearance for FREEZE DRIED FICIN, manufactured by Biological Corp. of America. The device is a Class 2 Immunology device with product code KSK cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K813404 · Biological Corp. of America · Immunology device
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Feb 1982
Decision
65d
Days
Class 2
Risk

K813404 is an FDA 510(k) clearance for the FREEZE DRIED FICIN. Classified as Solution, Stabilized Enzyme (product code KSK), Class II - Special Controls.

Submitted by Biological Corp. of America (Mchenry, US). The FDA issued a Cleared decision on February 10, 1982 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.9400 - the FDA immunology 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 - K813404

510(k) Number K813404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date February 10, 1982
Days to Decision 65 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 105d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSK Device Classification - Class 2, Special Controls

Product Code KSK Solution, Stabilized Enzyme
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9400
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 Immunology devices follow this clearance model.

K813404 · FREEZE DRIED FICIN
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