Cleared Traditional

BIO-UREA (K834029) - FDA 510(k) Clearance

Class I Microbiology device.

K834029 · Remel Co. · Microbiology device
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Dec 1983
Decision
38d
Days
Class 1
Risk

K834029 is an FDA 510(k) clearance for the BIO-UREA. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1983 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Remel Co. devices

Submission Details

510(k) Number K834029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1983
Decision Date December 30, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 102d · This submission: 38d
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 K834029.
BBL(R) DMACA INDOLE REAGENT DROPPERS
K912480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1991
PATHODX PYR KIT
K902037 · Diagnostic Products Corp. · Jun 1990
LD PRESUMPTO QUAD
K871907 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
ONPG SOLUTION
K863601 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
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