Cleared Traditional

K811283 - JEMBEC TRANSPORT SYSTEM

K811283 is an FDA 510(k) clearance for JEMBEC TRANSPORT SYSTEM, manufactured by Biolog, Inc.. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K811283 · Biolog, Inc. · Microbiology device
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Jun 1981
Decision
35d
Days
Class 1
Risk

K811283 is an FDA 510(k) clearance for the JEMBEC TRANSPORT SYSTEM. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Biolog, Inc. (Walker, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Biolog, Inc. devices

FDA 510(k) Submission Details - K811283

510(k) Number K811283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1981
Decision Date June 12, 1981
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

JTW Device Classification - Class 1, General Controls

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTW System, Transport, Aerobic

All 30
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K811283.
PRESERV TRANSPORT & CULTURE PACK
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MINI-TIP CULTURETTE
K803298 · Marion Laboratories, Inc. · Jan 1981
CULSWAB CAT.#978 & 979
K802023 · Pollak (Intl.), Ltd. · Sep 1980
PDC 304 DOUBLE SWAB CULTURE COLLECTION
K791953 · Precision Dynamics Corp. · Oct 1979