Cleared Traditional

COLUMBIA SHEEP BLOOD AGAR 5% (K830075) - FDA 510(k) Clearance

Class I Immunology device.

K830075 · bioMerieux, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1983
Decision
29d
Days
Class 1
Risk

K830075 is an FDA 510(k) clearance for the COLUMBIA SHEEP BLOOD AGAR 5%. Classified as Culture Media, Non-selective And Non-differential (product code JSG), 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 866.2300 - 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 K830075 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 JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 208
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K830075.
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA
K881115 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1988
ANAEROBIC BLOOD AGAR (CDC FORMULATION)
K871089 · bioMerieux, Inc. · Apr 1987
TRYPTIC SOY AGAR
K871098 · bioMerieux, Inc. · Apr 1987
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
K851250 · Roche Diagnostic Systems, Inc. · Apr 1985
THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR
K844526 · bioMerieux, Inc. · Jan 1985
NUTRIENT BROTH
K844528 · bioMerieux, Inc. · Jan 1985