Cleared Traditional

K843764 - BIOTIS SCHAEDLER AGAR & BROTH

K843764 is the FDA 510(k) clearance for BIOTIS SCHAEDLER AGAR & BROTH by Otisville Biotech, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K843764 · Otisville Biotech, Inc. · Microbiology device
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Oct 1984
Decision
15d
Days
Class 1
Risk

K843764 is an FDA 510(k) clearance for the BIOTIS SCHAEDLER AGAR & BROTH. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1984 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 K843764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1984
Decision Date October 10, 1984
Days to Decision 15 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
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K843764.
FLUID THIOGLYCOLLATE MEDIUM W/INDICATOR
K844537 · bioMerieux, Inc. · Jan 1985
COOKED MEAT MEDIUM
K844538 · bioMerieux, Inc. · Jan 1985
TRYPTIC SOY BROTH
K844541 · bioMerieux, Inc. · Jan 1985
MAXIMUM RECOVERY DILUENT
K841662 · Oxoid U.S.A., Inc. · Jun 1984
BIPHASIC BLOOD CULTURE BOTTLE
K842036 · Gibco Laboratories Life Technologies, Inc. · Jun 1984
CAMPYLOBACTER THIOGLYCOLLATE MED
K841303 · Anaerobe Systems · Apr 1984