Cleared Traditional

K920257 - NIACIN CONTROL DISKS

K920257 is the FDA 510(k) clearance for NIACIN CONTROL DISKS by Remel Co.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K920257 · Remel Co. · Microbiology device
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Apr 1992
Decision
92d
Days
Class 1
Risk

K920257 is an FDA 510(k) clearance for the NIACIN CONTROL DISKS. 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 April 22, 1992 after a review of 92 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 K920257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1992
Decision Date April 22, 1992
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
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 K920257.
DRYSLIDE(TM), PYR
K921583 · Difco Laboratories, Inc. · Jun 1992
BACTIDROP NINHYDRIN
K920971 · Remel Co. · May 1992
BACTIDROP PYR
K920972 · Remel Co. · May 1992
BACTIDROP(TM) FERRIC CHLORIDE (10%)
K913002 · Remel Co. · Sep 1991
BACTIDROP(TM) VOGES-PROSKAUER A
K913003 · Remel Co. · Sep 1991
BACTIDROP(TM) DOBELL & O'CONNOR IODINE
K913006 · Remel Co. · Sep 1991