Cleared Traditional

K884720 - GERM TUBE SOLUTION

K884720 is an FDA 510(k) clearance for GERM TUBE SOLUTION, manufactured by Remel Co.. The device is a Class 1 Microbiology device with product code JXC cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K884720 · Remel Co. · Microbiology device
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Jun 1989
Decision
204d
Days
Class 1
Risk

K884720 is an FDA 510(k) clearance for the GERM TUBE SOLUTION. Classified as Kit, Screening, Yeast (product code JXC), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 2, 1989 after a review of 204 days - an extended review 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: 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 - K884720

510(k) Number K884720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1988
Decision Date June 02, 1989
Days to Decision 204 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
102d slower than avg
Panel avg: 102d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

JXC Device Classification - Class 1, General Controls

Product Code JXC Kit, Screening, Yeast
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.