Cleared Traditional

K843483 - PHARMA-PLAST PETRI DISH

K843483 is an FDA 510(k) clearance for PHARMA-PLAST PETRI DISH, manufactured by Zimmar Consulting , Ltd.. The device is a Class 1 Microbiology device with product code LIB cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K843483 · Zimmar Consulting , Ltd. · Microbiology device
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Sep 1984
Decision
15d
Days
Class 1
Risk

K843483 is an FDA 510(k) clearance for the PHARMA-PLAST PETRI DISH. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Zimmar Consulting , Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1984 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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.

FDA 510(k) Submission Details - K843483

510(k) Number K843483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date September 21, 1984
Days to Decision 15 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
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

LIB Device Classification - Class 1, General Controls

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - LIB Device, General Purpose, Microbiology, Diagnostic

All 39
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K843483.
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K841632 · Plastic Injectors, Inc. · May 1984
K843483 · PHARMA-PLAST PETRI DISH
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