Cleared Traditional

K822119 - ACCESSORY MEDIA FOR FLOW TITERTEK MIC

K822119 is the FDA 510(k) clearance for ACCESSORY MEDIA FOR FLOW TITERTEK MIC by Flow Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTZ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K822119 · Flow Laboratories, Inc. · Microbiology device
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Aug 1982
Decision
15d
Days
Class 2
Risk

K822119 is an FDA 510(k) clearance for the ACCESSORY MEDIA FOR FLOW TITERTEK MIC. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1982 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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 Flow Laboratories, Inc. devices

Submission Details

510(k) Number K822119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1982
Decision Date August 03, 1982
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. No clinical trials required.

Device Classification

Product Code JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

All 25
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K822119.
CHOCOLATE AGAR MUELLERH-HINTON BASE
K840066 · Otisville Biotech, Inc. · Feb 1984
MUELLER-HINTON AGAR PLATE
K834421 · Otisville Biotech, Inc. · Feb 1984
MUELLER HINTON
K830060 · bioMerieux, Inc. · Feb 1983
MUELLER HINTON W/5% SHEEP'S BLOOD
K821607 · Hardy Media · Jul 1982
MUELLER HINTON AGAR
K811646 · Hardy Media · Jul 1981
MUELLER-HINTON
K811608 · Micro Media Laboratories · Jun 1981