Cleared Traditional

K862390 - BIOTIS BORDET GENGOU AGAR

K862390 is the FDA 510(k) clearance for BIOTIS BORDET GENGOU AGAR by Otisville Biotech, Inc.. It is a Class 1 Microbiology device (product code KZI) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K862390 · Otisville Biotech, Inc. · Microbiology device
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Jul 1986
Decision
9d
Days
Class 1
Risk

K862390 is an FDA 510(k) clearance for the BIOTIS BORDET GENGOU AGAR. Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by Otisville Biotech, Inc. (Otisville, US). The FDA issued a Cleared decision on July 3, 1986 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2330 - 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 K862390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1986
Decision Date July 03, 1986
Days to Decision 9 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
93d faster than avg
Panel avg: 102d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZI Culture Media, Enriched
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2330
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 - KZI Culture Media, Enriched

All 29
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K862390.
HORSE BLOOD AGAR, ENRICHED
K871092 · bioMerieux, Inc. · Apr 1987
LOMBARD DOWELL AGAR BASE
K864014 · Gibco Laboratories Life Technologies, Inc. · Oct 1986
VACUTAINER BRAND AGAR SLANT
K862761 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1986
BIOTIS COOKED MEAT
K860410 · Otisville Biotech, Inc. · Feb 1986
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR
K854064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG
K843065 · Otisville Biotech, Inc. · Aug 1984