Cleared Traditional

K860402 - BIOTIS BISMUTH SULFITE AGAR

K860402 is the FDA 510(k) clearance for BIOTIS BISMUTH SULFITE AGAR by Otisville Biotech, Inc.. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K860402 · Otisville Biotech, Inc. · Microbiology device
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Feb 1986
Decision
21d
Days
Class 1
Risk

K860402 is an FDA 510(k) clearance for the BIOTIS BISMUTH SULFITE AGAR. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Otisville Biotech, Inc. (Otisville, US). The FDA issued a Cleared decision on February 24, 1986 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Otisville Biotech, Inc. devices

Submission Details

510(k) Number K860402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1986
Decision Date February 24, 1986
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 JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 187
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K860402.
BIOTIS MAC-MUG
K860385 · Otisville Biotech, Inc. · Feb 1986
BIOTIS SF BROTH
K860386 · Otisville Biotech, Inc. · Feb 1986
BIOTIS KF STREPTOCOCCUS AGAR
K860388 · Otisville Biotech, Inc. · Feb 1986
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
K855110 · Gibco Laboratories Life Technologies, Inc. · Jan 1986
TERGITOL 7 AGAR
K853691 · Micro Media Laboratories · Sep 1985
AEROMONAS AGAR(XDCA)
K852789 · Gibco Laboratories Life Technologies, Inc. · Jul 1985