Cleared Traditional

K953632 - SERIM PYLORITEK TEST KIT

K953632 is the FDA 510(k) clearance for SERIM PYLORITEK TEST KIT by Serim Research Corp.. It is a Class 1 Microbiology device (product code LYR) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K953632 · Serim Research Corp. · Microbiology device
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Dec 1995
Decision
151d
Days
Class 1
Risk

K953632 is an FDA 510(k) clearance for the SERIM PYLORITEK TEST KIT. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on December 18, 1995 after a review of 151 days - an extended review 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: 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 Serim Research Corp. devices

Submission Details

510(k) Number K953632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1995
Decision Date December 18, 1995
Days to Decision 151 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 102d · This submission: 151d
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 38
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K953632.
PYLORI IGG ELISA TEST SYSTEM
K961221 · Armkel, LLC · Jul 1996
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
K952517 · Quidel Corp. · Feb 1996
HM-CAP CONTROL PANEL
K954926 · E-Z-Em, Inc. · Jan 1996
PREMIER(TM) H. PYLORY
K945558 · Meridian Diagnostics, Inc. · Mar 1995
IMMUNOCARD H. PYLORI
K941560 · Meridian Diagnostics, Inc. · Dec 1994
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
K923445 · Hycor Biomedical, Inc. · Sep 1992