Cleared Traditional

K812467 - PGUA-INDOL MICROTUBE

K812467 is an FDA 510(k) clearance for PGUA-INDOL MICROTUBE, manufactured by Carr Microbiologicals. The device is a Class 1 Microbiology device with product code JSE cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812467 · Carr Microbiologicals · Microbiology device
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Sep 1981
Decision
14d
Days
Class 1
Risk

K812467 is an FDA 510(k) clearance for the PGUA-INDOL MICROTUBE. Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Carr Microbiologicals (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981 after a review of 14 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 Carr Microbiologicals devices

FDA 510(k) Submission Details - K812467

510(k) Number K812467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date September 14, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

JSE Device Classification - Class 1, General Controls

Product Code JSE Culture Media, Multiple Biochemical Test
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 - JSE Culture Media, Multiple Biochemical Test

All 44
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K812467.
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K820810 · Biomedica, Inc. · Apr 1982
SUCROSE
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SIM MEDIUM
K792420 · Isle Media and Sterile Products, Inc. · Dec 1979
DECARBOXYLASE MOELLER BASE WITH OR WITH-
K792425 · Isle Media and Sterile Products, Inc. · Dec 1979