Cleared Traditional

K830179 - BIOCELL SPINAL FLUID CONTROL

K830179 is the FDA 510(k) clearance for BIOCELL SPINAL FLUID CONTROL by Biocell Laboratories, Inc.. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K830179 · Biocell Laboratories, Inc. · Immunology device
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Feb 1983
Decision
31d
Days
Class 1
Risk

K830179 is an FDA 510(k) clearance for the BIOCELL SPINAL FLUID CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Biocell Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on February 18, 1983 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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.

View all Biocell Laboratories, Inc. devices

Submission Details

510(k) Number K830179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1983
Decision Date February 18, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 104d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 477
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