Cleared Traditional

K920973 - BACTIDROP INDOLE (ERLICH'S)

K920973 is the FDA 510(k) clearance for BACTIDROP INDOLE (ERLICH'S) by Remel Co.. It is a Class 1 Microbiology device (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

Submission Details

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.

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 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