Cleared Traditional

PREPARED TRYPTIC SOY AGAR 100 MM PLATE (K833507) - FDA 510(k) Clearance

Class I Microbiology device.

K833507 · Lavco Laboratory, Inc. · Microbiology device
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Dec 1983
Decision
51d
Days
Class 1
Risk

K833507 is an FDA 510(k) clearance for the PREPARED TRYPTIC SOY AGAR 100 MM PLATE. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Lavco Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 1, 1983 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Lavco Laboratory, Inc. devices

Submission Details

510(k) Number K833507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1983
Decision Date December 01, 1983
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 61
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K833507.
COOKED MEAT MEDIUM
K844538 · bioMerieux, Inc. · Jan 1985
TRYPTIC SOY BROTH
K844541 · bioMerieux, Inc. · Jan 1985
EUGONIC AGAR
K834206 · Acumedia Manufacturers, Inc. · Jan 1984
BRUCELLA AGAR MODIFIED
K833299 · Acumedia Manufacturers, Inc. · Nov 1983
SABOURAUD DEXTROSE AGAR, EMMONS
K833296 · Acumedia Manufacturers, Inc. · Oct 1983
ACIDICASE-BB1
K833209 · Acumedia Manufacturers, Inc. · Oct 1983