Cleared Traditional

K871532 - TOMTEC GRAM STAINER CRYSTAL VIOLET

K871532 is the FDA 510(k) clearance for TOMTEC GRAM STAINER CRYSTAL VIOLET by Remel Co.. It is a Class 1 Pathology device (product code JTS) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K871532 · Remel Co. · Pathology device
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Apr 1987
Decision
9d
Days
Class 1
Risk

K871532 is an FDA 510(k) clearance for the TOMTEC GRAM STAINER CRYSTAL VIOLET. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on April 29, 1987 after a review of 9 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 K871532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1987
Decision Date April 29, 1987
Days to Decision 9 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
68d faster than avg
Panel avg: 77d · This submission: 9d
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 K871532.
TB KINYOUN CARBOLFUCHSIN
K872187 · Remel Co. · Jul 1987
METHANOL, ABSOLUTE
K872189 · Remel Co. · Jul 1987
SPOTTEST FLAGELLA STAIN
K871606 · Difco Laboratories, Inc. · May 1987
GRAM STAIN KIT
K853896 · Sigma Diagnostics, Inc. · Oct 1985
GRAM STAIN REAGENTS AND KIT
K813369 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
DROPPERS, SOLUTION, IODINE
K781061 · Marion Laboratories, Inc. · Aug 1978