Cleared Traditional

K955826 - GIBSON ID-M. CAT.

K955826 is an FDA 510(k) clearance for GIBSON ID-M. CAT., manufactured by Gibson Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K955826 · Gibson Laboratories, Inc. · Microbiology device
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Feb 1996
Decision
65d
Days
Class 1
Risk

K955826 is an FDA 510(k) clearance for the GIBSON ID-M. CAT.. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Gibson Laboratories, Inc. (Lexington, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 65 days - a notably fast clearance cycle.

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: 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 Gibson Laboratories, Inc. devices

FDA 510(k) Submission Details - K955826

510(k) Number K955826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date February 29, 1996
Days to Decision 65 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 102d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

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 195
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K955826.
IDS RAPID CB PLUS SYSTEM
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DRYSLIDE CARTARRHALIS
K954783 · Difco Laboratories, Inc. · Feb 1996
LYFO(TM) DIFFERIENTAL DISK-PYR
K954812 · Microbiologics, Inc. · Dec 1995
LYFO(TM) DIFFERENTIAL DISK
K951889 · Microbiologics, Inc. · Aug 1995