Cleared Traditional

K964014 - KENLOR H. PYLORI CONTROL SERUM

K964014 is an FDA 510(k) clearance for KENLOR H. PYLORI CONTROL SERUM, manufactured by Kenlor Industries, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K964014 · Kenlor Industries, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
147d
Days
Class 1
Risk

K964014 is an FDA 510(k) clearance for the KENLOR H. PYLORI CONTROL SERUM. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Kenlor Industries, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 3, 1997 after a review of 147 days - within the typical 510(k) review window.

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: 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 Kenlor Industries, Inc. devices

FDA 510(k) Submission Details - K964014

510(k) Number K964014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date March 03, 1997
Days to Decision 147 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
45d slower than avg
Panel avg: 102d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

LYR Device Classification - Class 1, General Controls

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 72
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K964014.
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · Boehringer Mannheim Corp. · Mar 1998
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146 · Consolidated Technologies, Inc. · Jul 1997
PYLORISET EIA-G (68926)
K971537 · Orion Diagnostica, Div. Orion Corp. · Jun 1997
ACCUMETER H. PYLORI TEST
K965099 · Chemtrak, Inc. · Feb 1997
H.PYLORI CONTROLS
K964675 · Pyramid Biological Corp. · Jan 1997
IMMUNOCARD H. PYLORI
K961508 · Meridian Diagnostics, Inc. · Jan 1997