Cleared Traditional

K833407 - SELECTO-DISC NOVOBIOCIN 5UG

K833407 is the FDA 510(k) clearance for SELECTO-DISC NOVOBIOCIN 5UG by Lab Ability, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K833407 · Lab Ability, Inc. · Microbiology device
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Dec 1983
Decision
91d
Days
Class 1
Risk

K833407 is an FDA 510(k) clearance for the SELECTO-DISC NOVOBIOCIN 5UG. 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 December 30, 1983 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lab Ability, Inc. devices

Submission Details

510(k) Number K833407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1983
Decision Date December 30, 1983
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
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 K833407.
SPOTTEST FERRIC CHLORIDE REAGENT
K840582 · Difco Laboratories, Inc. · Feb 1984
SPOTTEST VOGES-PROSKAUER REAGENT B
K840583 · Difco Laboratories, Inc. · Feb 1984
DIFFERENTIATION DISKS HIPPURATE
K834581 · Difco Laboratories, Inc. · Feb 1984
HAEMOPHILUS IDENTIFICATION TEST KIT
K833963 · Remel Co. · Dec 1983
PVP IODINE
K834022 · Remel Co. · Dec 1983
BIO-ORNITHINE
K834028 · Remel Co. · Dec 1983