Cleared Traditional

K812916 - MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D

K812916 is the FDA 510(k) clearance for MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D by General Diagnostics. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K812916 · General Diagnostics · Microbiology device
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Nov 1981
Decision
18d
Days
Class 2
Risk

K812916 is an FDA 510(k) clearance for the MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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 General Diagnostics devices

Submission Details

510(k) Number K812916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1981
Decision Date November 06, 1981
Days to Decision 18 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
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
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 - JTN Susceptibility Test Discs, Antimicrobial

All 292
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K812916.
METRONIDAZOLE 80MCG. SENSI-DISC
K813387 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK
K812994 · General Diagnostics · Dec 1981
MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK
K812993 · General Diagnostics · Nov 1981
MOXALACTAM 30 MCG. SENSITIVITY DISCS
K812228 · Difco Laboratories, Inc. · Oct 1981
TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK
K812783 · General Diagnostics · Oct 1981
MOXALACTAM 30MCG. SENSI-DISC
K812844 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981