Cleared Traditional

K953362 - PREMIER EHEC

K953362 is an FDA 510(k) clearance for PREMIER EHEC, manufactured by Meridian Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code GNA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K953362 · Meridian Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
120d
Days
Class 1
Risk

K953362 is an FDA 510(k) clearance for the PREMIER EHEC. Classified as Antisera, All Types, Escherichia Coli (product code GNA), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3255 - 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 - K953362

510(k) Number K953362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date November 14, 1995
Days to Decision 120 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
18d slower than avg
Panel avg: 102d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

GNA Device Classification - Class 1, General Controls

Product Code GNA Antisera, All Types, Escherichia Coli
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3255
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 - GNA Antisera, All Types, Escherichia Coli

All 10
Devices cleared under the same product code (GNA) and FDA review panel - the closest regulatory comparables to K953362.
DRYSPOT E.COLI 0157 KIT
K993401 · Oxoid , Ltd. · Feb 2000
VTEC-RPLA SEIKEN
K981734 · Denka Seiken'S · Sep 1998
WELLCOLEX E-COLI OI57 ZC60
K962028 · Murex Diagnostics, Inc. · Nov 1996
PREMIER EHEC
K950167 · Meridian Diagnostics, Inc. · Apr 1995
RIM E.COLI 0157:H7 LATEX TEST
K933457 · Remel Co. · Apr 1994
E. COLI 0157 LATEX TEST
K903714 · Pro-Lab, Inc. · Jan 1991