Cleared Traditional

SERIM PYLORITEK REAGENT STRIPS (K936034) - FDA 510(k) Clearance

Class I Microbiology device.

K936034 · Serim Research Corp. · Microbiology device
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Apr 1994
Decision
127d
Days
Class 1
Risk

K936034 is an FDA 510(k) clearance for the SERIM PYLORITEK REAGENT STRIPS. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on April 21, 1994 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 K936034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1993
Decision Date April 21, 1994
Days to Decision 127 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
25d slower than avg
Panel avg: 102d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 243
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K936034.
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ONPG SOLUTION
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MS-2 BACTERIAL IDENTI. SYS
K830099 · Abbott Laboratories · Feb 1983
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP
K823718 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1983
BACTEC NAP TB DIFFERENTIATION TEST
K822946 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1982