Cleared Traditional

K852064 - DRI-FORM PSEUDOMONAS AGAR F

K852064 is an FDA 510(k) clearance for DRI-FORM PSEUDOMONAS AGAR F, manufactured by Gibco Laboratories Life Technologies, Inc.. The device is a Class 1 Microbiology device with product code JSH cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K852064 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
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Jun 1985
Decision
22d
Days
Class 1
Risk

K852064 is an FDA 510(k) clearance for the DRI-FORM PSEUDOMONAS AGAR F. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Gibco Laboratories Life Technologies, Inc. (Madison, US). The FDA issued a Cleared decision on June 4, 1985 after a review of 22 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 Gibco Laboratories Life Technologies, Inc. devices

FDA 510(k) Submission Details - K852064

510(k) Number K852064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1985
Decision Date June 04, 1985
Days to Decision 22 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
80d faster than avg
Panel avg: 102d · This submission: 22d
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
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