Cleared Traditional

SERIM PYLORITEK TEST KIT (K953632) - FDA 510(k) Clearance

Class I Microbiology device.

K953632 · Serim Research Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 90
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K953632.
Hp Detect™ Stool Antigen ELISA
K232892 · Biomerica, Inc. · Dec 2023
Premier HpSA Flex (619096)
K230901 · Meridian Bioscience, Inc. · Jul 2023
Curian HpSA, Curian Analyzer
K192817 · Meridian Bioscience, Inc. · Mar 2020
Vstrip H. pylori Antigen Rapid Test
K183573 · Panion & BF Biotech, Inc. · Mar 2019
PREMIER Platinum HpSA PLUS
K182559 · Meridian Bioscience, Inc. · Nov 2018
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · DiaSorin, Inc. · Aug 2018