Cleared Traditional

BLOOD AGAR(TSA W/5% SHEEP BLOOD) (K830078) - FDA 510(k) Clearance

Class I Immunology device.

K830078 · bioMerieux, Inc. · Immunology device
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Feb 1983
Decision
29d
Days
Class 1
Risk

K830078 is an FDA 510(k) clearance for the BLOOD AGAR(TSA W/5% SHEEP BLOOD). Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by bioMerieux, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2330 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all bioMerieux, Inc. devices

Submission Details

510(k) Number K830078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date February 09, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZI Culture Media, Enriched
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2330
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 - KZI Culture Media, Enriched

All 50
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K830078.
FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU
K872193 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987
HORSE BLOOD AGAR, ENRICHED
K871092 · bioMerieux, Inc. · Apr 1987
VACUTAINER BRAND AGAR SLANT
K862761 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1986
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR
K854064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
CHOCOLATE AGAR, ENRICHED
K830074 · bioMerieux, Inc. · Feb 1983