Cleared Traditional

K920973 - BACTIDROP INDOLE (ERLICH'S)

K920973 is an FDA 510(k) clearance for BACTIDROP INDOLE (ERLICH'S), manufactured by Remel Co.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K920973 · Remel Co. · Microbiology device
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Jun 1992
Decision
109d
Days
Class 1
Risk

K920973 is an FDA 510(k) clearance for the BACTIDROP INDOLE (ERLICH'S). 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 June 19, 1992 after a review of 109 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 Remel Co. devices

FDA 510(k) Submission Details - K920973

510(k) Number K920973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date June 19, 1992
Days to Decision 109 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
7d slower than avg
Panel avg: 102d · This submission: 109d
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 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K920973.
DRYSLIDE(TM) INDOLE
K925747 · Difco Laboratories, Inc. · Jan 1993
INDOXYL ACETATE DISK
K923700 · Remel Co. · Oct 1992
LAP DISK
K923827 · Remel Co. · Sep 1992
DRYSLIDE(TM), PYR
K921583 · Difco Laboratories, Inc. · Jun 1992
BACTIDROP NINHYDRIN
K920971 · Remel Co. · May 1992
BACTIDROP PYR
K920972 · Remel Co. · May 1992