Cleared Traditional

K851344 - OXIDATIVE FORMENTIVE MEDIUM

K851344 is an FDA 510(k) clearance for OXIDATIVE FORMENTIVE MEDIUM, manufactured by Micro Media Laboratories. The device is a Class 1 Microbiology device with product code JSH cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K851344 · Micro Media Laboratories · Microbiology device
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Apr 1985
Decision
18d
Days
Class 1
Risk

K851344 is an FDA 510(k) clearance for the OXIDATIVE FORMENTIVE MEDIUM. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on April 22, 1985 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 Micro Media Laboratories devices

FDA 510(k) Submission Details - K851344

510(k) Number K851344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1985
Decision Date April 22, 1985
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.

JSH Device Classification - Class 1, General Controls

Product Code JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 118
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K851344.
TRIPLE SUGAR IRON AGAR
K851597 · Preferred Micro-Media · May 1985
BIGGY AGAR NICKERSONS MEDIUM
K851576 · Preferred Micro-Media · May 1985
UREA AGAR
K851602 · Preferred Micro-Media · May 1985
BROM CRESOL PURPLE STARCH
K851343 · Micro Media Laboratories · Apr 1985
PURPLE BROTH
K851345 · Micro Media Laboratories · Apr 1985
PHENYLALANINE AGAR
K851346 · Micro Media Laboratories · Apr 1985