Cleared Traditional

K810541 - BETA LYSIN DISK

K810541 is the FDA 510(k) clearance for BETA LYSIN DISK by Remel Co.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K810541 · Remel Co. · Microbiology device
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Mar 1981
Decision
18d
Days
Class 1
Risk

K810541 is an FDA 510(k) clearance for the BETA LYSIN DISK. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 18 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 K810541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1981
Decision Date March 17, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
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 K810541.
BILE DISK
K812083 · Remel Co. · Aug 1981
SPS DISK
K812084 · Remel Co. · Aug 1981
STAPH-IDENT
K811998 · Analytical Products, Inc. · Jul 1981
OPTOCHIN DIAGNOSTIC DISC
K802496 · Oxoid U.S.A., Inc. · Nov 1980
BACTIRACIN DIAGNOSTIC DISC
K802497 · Oxoid U.S.A., Inc. · Nov 1980
X-FACTOR DISCS
K802500 · Oxoid U.S.A., Inc. · Nov 1980