Cleared Traditional

K936034 - SERIM PYLORITEK REAGENT STRIPS

K936034 is an FDA 510(k) clearance for SERIM PYLORITEK REAGENT STRIPS, manufactured by Serim Research Corp.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 127-day FDA review.

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

FDA 510(k) Submission Details - K936034

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.

JTO Device Classification - Class 1, General Controls

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 195
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K936034.
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN
K945883 · Microbiologics, Inc. · Apr 1995
DISPENS-O-DISC(TM) NITROCEFIN
K941016 · Difco Laboratories, Inc. · Jun 1994
BACTICARD STREP
K936021 · Remel Co. · May 1994
BACTICARD E. COLI
K934986 · Remel Co. · Feb 1994
PYR TEST KIT
K931865 · Hardy Diagnostics · Dec 1993
VISI-SPOT
K932752 · J.S. Medical Assoc. · Nov 1993