Cleared Traditional

K872187 - TB KINYOUN CARBOLFUCHSIN

K872187 is the FDA 510(k) clearance for TB KINYOUN CARBOLFUCHSIN by Remel Co.. It is a Class 1 Pathology device (product code JTS) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K872187 · Remel Co. · Pathology device
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Jul 1987
Decision
51d
Days
Class 1
Risk

K872187 is an FDA 510(k) clearance for the TB KINYOUN CARBOLFUCHSIN. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on July 29, 1987 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology 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 K872187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date July 29, 1987
Days to Decision 51 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 77d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTS Stains, Microbiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - JTS Stains, Microbiologic

All 17
Devices cleared under the same product code (JTS) and FDA review panel - the closest regulatory comparables to K872187.
TB METHYLENE BLUE
K872184 · Remel Co. · Jul 1987
LIGHT GREEN
K872185 · Remel Co. · Jul 1987
SULFURIC ACID 10%
K872186 · Remel Co. · Jul 1987
METHANOL, ABSOLUTE
K872189 · Remel Co. · Jul 1987
SPOTTEST FLAGELLA STAIN
K871606 · Difco Laboratories, Inc. · May 1987
TOMTEC GRAM STAINER CRYSTAL VIOLET
K871532 · Remel Co. · Apr 1987