Cleared Traditional

K923342 - MICROBACT SOLID PLATE SYSTEMS

K923342 is an FDA 510(k) clearance for MICROBACT SOLID PLATE SYSTEMS, manufactured by Radiometer America, Inc.. The device is a Class 1 Microbiology device with product code JJS cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K923342 · Radiometer America, Inc. · Microbiology device
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Sep 1992
Decision
98d
Days
Class 1
Risk

K923342 is an FDA 510(k) clearance for the MICROBACT SOLID PLATE SYSTEMS. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on September 22, 1992 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Radiometer America, Inc. devices

FDA 510(k) Submission Details - K923342

510(k) Number K923342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1992
Decision Date September 22, 1992
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

JJS Device Classification - Class 1, General Controls

Product Code JJS Controls For Blood-gases, (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJS Controls For Blood-gases, (assayed And Unassayed)

All 57
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K923342.
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
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K920285 · Phoenix Diagnostics, Inc. · Jul 1992
RNA MEDICAL'S EQUIL 55
K922357 · Bionostics, Inc. · Jun 1992
QUALICHECK 4
K915399 · Radiometer America, Inc. · Jan 1992