Cleared Traditional

K843050 - GRAM STAIN (FDA 510(k) Clearance)

Class I Microbiology device.

K843050 · Reagent Laboratory, Inc. · Microbiology device
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Sep 1984
Decision
39d
Days
Class 1
Risk

K843050 is an FDA 510(k) clearance for the GRAM STAIN. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.1850 - 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 Reagent Laboratory, Inc. devices

Submission Details

510(k) Number K843050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1984
Decision Date September 11, 1984
Days to Decision 39 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 102d · This submission: 39d
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.