Cleared Traditional

MICROBACT SOLID PLATE SYSTEMS (K923342) - FDA 510(k) Clearance

Class I Microbiology device.

K923342 · Radiometer America, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 22
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K923342.
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
K002120 · Bio-Rad · Aug 2000
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
K972861 · Instrumentation Laboratory CO · Aug 1997
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224 · Ciba Corning Diagnostics Corp. · Jan 1995
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
K872196 · American Dade · Jul 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036 · Ciba Corning Diagnostics Corp. · Jan 1987
AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
K832003 · American Dade · Aug 1983