Cleared Traditional

K840504 - SDL NEISSERIA MENINGITIDES GR. 2

K840504 is an FDA 510(k) clearance for SDL NEISSERIA MENINGITIDES GR. 2, manufactured by Scientific Device Laboratory, Inc.. The device is a Class 1 Microbiology device with product code LSC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K840504 · Scientific Device Laboratory, Inc. · Microbiology device
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Mar 1984
Decision
46d
Days
Class 1
Risk

K840504 is an FDA 510(k) clearance for the SDL NEISSERIA MENINGITIDES GR. 2. Classified as Neisseria Controls (product code LSC), Class I - General Controls.

Submitted by Scientific Device Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 46 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 Scientific Device Laboratory, Inc. devices

FDA 510(k) Submission Details - K840504

510(k) Number K840504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date March 23, 1984
Days to Decision 46 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
56d faster than avg
Panel avg: 102d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

LSC Device Classification - Class 1, General Controls

Product Code LSC Neisseria Controls
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 - LSC Neisseria Controls

Devices cleared under the same product code (LSC) and FDA review panel - the closest regulatory comparables to K840504.
HAEMOPHILUS INFLUENZAE TYPE B
K840506 · Scientific Device Laboratory, Inc. · Apr 1984
SDL NEISSERIA MENNINGITIDIS GR. X
K840505 · Scientific Device Laboratory, Inc. · Mar 1984
NEISSERIA MENINGITIDIS GR. Y
K840507 · Scientific Device Laboratory, Inc. · Mar 1984
NEISSERIA MENINGITIDIS GR. B
K840509 · Scientific Device Laboratory, Inc. · Mar 1984
NEISSERIA MENINGITIDIS GR. A
K840510 · Scientific Device Laboratory, Inc. · Mar 1984
NEISSERIA MENINGITIDIS CONTROL
K840514 · Scientific Device Laboratory, Inc. · Mar 1984