Cleared Traditional

K923700 - INDOXYL ACETATE DISK

K923700 is the FDA 510(k) clearance for INDOXYL ACETATE DISK by Remel Co.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K923700 · Remel Co. · Microbiology device
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Oct 1992
Decision
73d
Days
Class 1
Risk

K923700 is an FDA 510(k) clearance for the INDOXYL ACETATE DISK. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 73 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 Remel Co. devices

Submission Details

510(k) Number K923700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1992
Decision Date October 05, 1992
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
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 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K923700.
INDOLE SPOT & INDOLE KOVACS REAGENT
K930718 · Hardy Diagnostics · Apr 1993
VOGUES-PROSKAUER REAGENT A & B
K930720 · Hardy Diagnostics · Apr 1993
DRYSLIDE(TM) INDOLE
K925747 · Difco Laboratories, Inc. · Jan 1993
LAP DISK
K923827 · Remel Co. · Sep 1992
BACTIDROP INDOLE (ERLICH'S)
K920973 · Remel Co. · Jun 1992
DRYSLIDE(TM), PYR
K921583 · Difco Laboratories, Inc. · Jun 1992