Cleared Traditional

K843560 - BACTO STAPHYLOCOCCUS LATEX TEST

K843560 is the FDA 510(k) clearance for BACTO STAPHYLOCOCCUS LATEX TEST by Difco Laboratories, Inc.. It is a Class 1 Microbiology device (product code JWX) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K843560 · Difco Laboratories, Inc. · Microbiology device
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Oct 1984
Decision
21d
Days
Class 1
Risk

K843560 is an FDA 510(k) clearance for the BACTO STAPHYLOCOCCUS LATEX TEST. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 21 days - a notably fast clearance 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: 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K843560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date October 01, 1984
Days to Decision 21 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
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JWX Kit, Screening, Staphylococcus Aureus
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.

Regulatory Peers - JWX Kit, Screening, Staphylococcus Aureus

Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K843560.
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