Cleared Traditional

K883641 - SELECTIVE RAPID UREA

K883641 is an FDA 510(k) clearance for SELECTIVE RAPID UREA, manufactured by Remel Co.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K883641 · Remel Co. · Microbiology device
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May 1989
Decision
252d
Days
Class 1
Risk

K883641 is an FDA 510(k) clearance for the SELECTIVE RAPID UREA. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on May 4, 1989 after a review of 252 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 Remel Co. devices

FDA 510(k) Submission Details - K883641

510(k) Number K883641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1988
Decision Date May 04, 1989
Days to Decision 252 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 102d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

LYR Device Classification - Class 1, General Controls

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.