Cleared Traditional

K963085 - LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III

K963085 is an FDA 510(k) clearance for LIQUID IMMUNOLOGY CONTROL LEVEL I, manufactured by International Enzymes, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K963085 · International Enzymes, Inc. · Chemistry device
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Aug 1996
Decision
12d
Days
Class 1
Risk

K963085 is an FDA 510(k) clearance for the LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by International Enzymes, Inc. (San Marcos, US). The FDA issued a Cleared decision on August 20, 1996 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 International Enzymes, Inc. devices

FDA 510(k) Submission Details - K963085

510(k) Number K963085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1996
Decision Date August 20, 1996
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 439
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