Cleared Traditional

K832436 - SELECTRO-DISC

K832436 is the FDA 510(k) clearance for SELECTRO-DISC by Lab Ability, Inc.. It is a Class 1 Immunology device (product code JTO) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K832436 · Lab Ability, Inc. · Immunology device
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Sep 1983
Decision
63d
Days
Class 1
Risk

K832436 is an FDA 510(k) clearance for the SELECTRO-DISC. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Lab Ability, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2660 - 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 Lab Ability, Inc. devices

Submission Details

510(k) Number K832436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date September 26, 1983
Days to Decision 63 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 104d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 149
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K832436.
BIO-UREA
K834029 · Remel Co. · Dec 1983
BACTROL GRAM SLIDE
K833901 · Difco Laboratories, Inc. · Dec 1983
RIME COLI KIT
K832587 · Austin Biological Laboratories · Oct 1983
ONPG DISCS
K832307 · Oxoid U.S.A., Inc. · Aug 1983
SPS DISCS
K832305 · Oxoid U.S.A., Inc. · Aug 1983
BILE AESCULIN DISCS
K832306 · Oxoid U.S.A., Inc. · Aug 1983