Cleared Traditional

K854732 - API 50 CHB (CULTURE MEDIA)

K854732 is the FDA 510(k) clearance for API 50 CHB (CULTURE MEDIA) by Dms Products, Inc.. It is a Class 1 Microbiology device (product code JST) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K854732 · Dms Products, Inc. · Microbiology device
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Mar 1986
Decision
99d
Days
Class 1
Risk

K854732 is an FDA 510(k) clearance for the API 50 CHB (CULTURE MEDIA). Classified as Kit, Fastidious Organisms (product code JST), Class I - General Controls.

Submitted by Dms Products, Inc. (Flemington, US). The FDA issued a Cleared decision on March 4, 1986 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 866.2660 - 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: 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 Dms Products, Inc. devices

Submission Details

510(k) Number K854732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1985
Decision Date March 04, 1986
Days to Decision 99 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 102d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JST Kit, Fastidious Organisms
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 - JST Kit, Fastidious Organisms

Devices cleared under the same product code (JST) and FDA review panel - the closest regulatory comparables to K854732.
BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM
K962423 · Becton Dickinson Microbiology Systems · Aug 1996
SYNTHETIC BROTH A.O.A.C.
K841661 · Oxoid U.S.A., Inc. · May 1984
RIM-HAEMOPHILUS 1 & 2
K832051 · Austin Biological Laboratories · Aug 1983
RIM-HAEMOPHILUS 2
K832239 · Austin Biological Laboratories · Aug 1983
STREPTOCOCUS ID PLATE
K831349 · Granite Diagnostics, Inc. · May 1983