Cleared Traditional

K812078 - GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)

K812078 is an FDA 510(k) clearance for GONOZYME (10 COPIES FRWD. W/ORIG. TO BG), manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code JTY cleared through the Traditional 510(k) pathway .

K812078 · Abbott Laboratories · Microbiology device
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Jul 1981
Decision
-
Days
Class 2
Risk

K812078 is an FDA 510(k) clearance for the GONOZYME (10 COPIES FRWD. W/ORIG. TO BG). Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 23, 1981.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2410 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K812078

510(k) Number K812078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received July 23, 1981
Decision Date July 23, 1981
Days to Decision -
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
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 Microbiology devices follow this clearance model.

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

All 52
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K812078.
NY FERMENTATION MEDIA
K822552 · Gibco Laboratories Life Technologies, Inc. · Sep 1982
THAYER MARTIN
K821602 · Hardy Media · Jul 1982
MARTIN-LEWIS/PRONG AGAR
K821551 · Gibco Laboratories Life Technologies, Inc. · Jun 1982
THAYER-MARTIN, GC AGAR BASE
K811645 · Hardy Media · Jul 1981
LAB-TEK JEMBEC G.C. CULTURE SYSTEM
K811382 · Miles Laboratories, Inc. · Jun 1981
GC AGAR
K811053 · Acumedia Manufacturers, Inc. · Apr 1981