Cleared Traditional

K811479 - CHODOLATE AGAR, ENRICHED

K811479 is an FDA 510(k) clearance for CHODOLATE AGAR, manufactured by Biomedia, Inc.. The device is a Class 2 Toxicology device with product code JTY cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K811479 · Biomedia, Inc. · Toxicology device
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Jun 1981
Decision
23d
Days
Class 2
Risk

K811479 is an FDA 510(k) clearance for the CHODOLATE AGAR, ENRICHED. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Biomedia, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 18, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.2410 - the FDA toxicology 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 Biomedia, Inc. devices

FDA 510(k) Submission Details - K811479

510(k) Number K811479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1981
Decision Date June 18, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 87d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTY Device Classification - Class 2, Special Controls

Product Code JTY Culture Media, For Isolation Of Pathogenic Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2410
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 Toxicology devices follow this clearance model.

Regulatory Peers - JTY Culture Media, For Isolation Of Pathogenic Neisseria

All 59
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K811479.
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
K812078 · Abbott Laboratories · Jul 1981
THAYER-MARTIN, GC AGAR BASE
K811645 · Hardy Media · Jul 1981
THAYER MARTIN AGAR
K811476 · Biomedia, Inc. · Jun 1981
LAB-TEK JEMBEC G.C. CULTURE SYSTEM
K811382 · Miles Laboratories, Inc. · Jun 1981
GC AGAR
K811053 · Acumedia Manufacturers, Inc. · Apr 1981
MODIFIED THAYER-MARTIN X AGAR
K800333 · Isle Media and Sterile Products, Inc. · Mar 1980