Cleared Traditional

K833319 - BIO-REX 70 RESIN 100-200 MESH PH6.2 (FDA 510(k) Clearance)

Class I Toxicology device.

K833319 · Biosan Laboratories, Inc. · Toxicology device
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Nov 1983
Decision
38d
Days
Class 1
Risk

K833319 is an FDA 510(k) clearance for the BIO-REX 70 RESIN 100-200 MESH PH6.2. Classified as Resins, Ion-exchange (product code KEA), Class I - General Controls.

Submitted by Biosan Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2230 - the FDA toxicology 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 Biosan Laboratories, Inc. devices

Submission Details

510(k) Number K833319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1983
Decision Date November 03, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 87d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KEA Resins, Ion-exchange
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2230
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.