Cleared Traditional

K843065 - BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG

K843065 is an FDA 510(k) clearance for BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG, manufactured by Otisville Biotech, Inc.. The device is a Class 1 Microbiology device with product code KZI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K843065 · Otisville Biotech, Inc. · Microbiology device
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Aug 1984
Decision
14d
Days
Class 1
Risk

K843065 is an FDA 510(k) clearance for the BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG. Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1984 after a review of 14 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.

FDA 510(k) Submission Details - K843065

510(k) Number K843065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1984
Decision Date August 20, 1984
Days to Decision 14 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
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

KZI Device Classification - Class 1, General Controls

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 50
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K843065.
CHOCOLATE AGAR
K851588 · Preferred Micro-Media · Apr 1985
CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL
K850724 · Rapid City Regional Hospital, Inc. · Mar 1985
ENRICHED CULTURE MEDIUM
K850735 · Roseville Medical Laboratoriesu · Mar 1985
CHOCOLATE AGAR
K841586 · Microline Scientific · May 1984
SHEEP BLOOD AGAR
K841748 · The Montana Deaconess Medical Center · May 1984
CHOCOLATE AGAR
K841749 · The Montana Deaconess Medical Center · May 1984
K843065 · BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG
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