Cleared Traditional

K854732 - API 50 CHB (CULTURE MEDIA)

K854732 is an FDA 510(k) clearance for API 50 CHB (CULTURE MEDIA), manufactured by Dms Products, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K854732

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.

JST Device Classification - Class 1, General Controls

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