Cleared Traditional

K923445 - PYLORAGEN HELICBACTER PYLORI TEST KIT -...

K923445 is the FDA 510(k) clearance for PYLORAGEN HELICBACTER PYLORI TEST KIT -... by Hycor Biomedical, Inc.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K923445 · Hycor Biomedical, Inc. · Microbiology device
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Sep 1992
Decision
65d
Days
Class 1
Risk

K923445 is an FDA 510(k) clearance for the PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - 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 Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K923445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1992
Decision Date September 11, 1992
Days to Decision 65 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
37d faster than avg
Panel avg: 102d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYR Helicobacter Pylori
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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 - LYR Helicobacter Pylori

All 44
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K923445.
PREMIER(TM) H. PYLORY
K945558 · Meridian Diagnostics, Inc. · Mar 1995
IMMUNOCARD H. PYLORI
K941560 · Meridian Diagnostics, Inc. · Dec 1994
FLEXSURE HP
K934863 · Smithkline Diagnostics, Inc. · May 1994
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · Quidel Corp. · Feb 1992
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255 · Hycor Biomedical, Inc. · Oct 1991
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442 · Quidel Corp. · Sep 1991