Cleared Traditional

K803027 - CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.

K803027 is the FDA 510(k) clearance for CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC. by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway .

K803027 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Dec 1980
Decision
-
Days
Class 1
Risk

K803027 is an FDA 510(k) clearance for the CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 22, 1980.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K803027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1980
Decision Date December 22, 1980
Days to Decision -
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 259
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K803027.
MYCOLOGY CULTURE SYSTEM
K802946 · Orion Diagnostica, Inc. · Dec 1980
CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC.
K803022 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
CDC ANAEROBE LAKED BL AGAR W/PARAMOMY.
K803024 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
CLOSTRIDIUM DIFFICILE AGAR BASE
K802495 · Oxoid U.S.A., Inc. · Dec 1980
CYE BIPHASIC BLOOD CULTURE MEDIUM
K802571 · Remel Co. · Dec 1980
CORN MEAL AGAR MEDIA
K800807 · Isle Media and Sterile Products, Inc. · Apr 1980