Cleared Traditional

K932879 - G C II AGAR WITH SENSIVITALEX

K932879 is the FDA 510(k) clearance for G C II AGAR WITH SENSIVITALEX by Becton Dickinson Microbiology Systems. It is a Class 2 Microbiology device (product code JSO) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K932879 · Becton Dickinson Microbiology Systems · Microbiology device
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Sep 1993
Decision
99d
Days
Class 2
Risk

K932879 is an FDA 510(k) clearance for the G C II AGAR WITH SENSIVITALEX. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on September 21, 1993 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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 Becton Dickinson Microbiology Systems devices

Submission Details

510(k) Number K932879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date September 21, 1993
Days to Decision 99 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 102d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 31
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K932879.
SYNERGY QUAD
K941443 · Remel Co. · Sep 1994
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co. · Sep 1994
GC II AGAR WITH ISOVITALEX
K932882 · Becton Dickinson Microbiology Systems · Sep 1993
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
HAEMOPHILUS TEST MEDIUM (HTM)AGAR
K894216 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
HAEMOPHILUS TEST MEDIUM (AGAR)
K892928 · Remel Co. · Jun 1989