Cleared Traditional

K843768 - BIOTIS KLIGLER IRON AGAR

K843768 is the FDA 510(k) clearance for BIOTIS KLIGLER IRON AGAR by Otisville Biotech, Inc.. It is a Class 1 Microbiology device (product code JSE) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K843768 · Otisville Biotech, Inc. · Microbiology device
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Oct 1984
Decision
15d
Days
Class 1
Risk

K843768 is an FDA 510(k) clearance for the BIOTIS KLIGLER IRON AGAR. Classified as Culture Media, Multiple Biochemical Test (product code JSE), 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 866.2320 - 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 K843768 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 JSE Culture Media, Multiple Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSE Culture Media, Multiple Biochemical Test

All 38
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K843768.
MOTILITY INDOLE ORNITHINE AGAR
K850547 · Hardy Media · Mar 1985
LYSINE IRON AGAR LIA
K850548 · Hardy Media · Mar 1985
SIM MEDIUM
K850551 · Hardy Media · Mar 1985
BIOTIS LD-PRESUMPTO QUADRANT PLATE
K842424 · Otisville Biotech, Inc. · Jul 1984
RIM STREP KIT
K842451 · Austin Biological Laboratories · Jul 1984
KLIGLER IRON AGAR
K834001 · Micro Media Laboratories · Dec 1983