Cleared Traditional

K943228 - MICROSPORIDIUM CONTROL SET

K943228 is an FDA 510(k) clearance for MICROSPORIDIUM CONTROL SET, manufactured by Meridian Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LJG cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K943228 · Meridian Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
113d
Days
Class 1
Risk

K943228 is an FDA 510(k) clearance for the MICROSPORIDIUM CONTROL SET. Classified as Quality Control Slides (product code LJG), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 27, 1994 after a review of 113 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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K943228

510(k) Number K943228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date October 27, 1994
Days to Decision 113 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 102d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

LJG Device Classification - Class 1, General Controls

Product Code LJG Quality Control Slides
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 - LJG Quality Control Slides

All 17
Devices cleared under the same product code (LJG) and FDA review panel - the closest regulatory comparables to K943228.
MICROSPORIDIUM CONTROL SLIDE
K924893 · Scientific Device Laboratory, Inc. · Jan 1993
CRYPTOSPORIDIUM CONTROL SLIDE
K890670 · Scientific Device Laboratory, Inc. · Mar 1989
GRAM STAIN CONTROL SLIDE
K890718 · Scientific Device Laboratory, Inc. · Mar 1989
ACID FAST BACILLI HISTOLOGY CONTROL SLIDES
K881106 · Sigma Diagnostics, Inc. · Apr 1988
SPIROCHETES HISTOLOGY CONTROL SLIDES
K881109 · Sigma Diagnostics, Inc. · Apr 1988
FUNGI HISTOLOGY CONTROL SLIDES
K881112 · Sigma Diagnostics, Inc. · Apr 1988