Cleared Traditional

K803027 - CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.

K803027 is an FDA 510(k) clearance for CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K803027

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.

JSJ Device Classification - Class 1, General Controls

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 271
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