Cleared Traditional

K850556 - CDC ANEROBIC BLOOD AGAR W/PEA

K850556 is the FDA 510(k) clearance for CDC ANEROBIC BLOOD AGAR W/PEA by Hardy Media. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K850556 · Hardy Media · Microbiology device
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Mar 1985
Decision
28d
Days
Class 1
Risk

K850556 is an FDA 510(k) clearance for the CDC ANEROBIC BLOOD AGAR W/PEA, ANEROBIC PEA. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 11, 1985 after a review of 28 days - a notably fast clearance cycle.

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: 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 Hardy Media devices

Submission Details

510(k) Number K850556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1985
Decision Date March 11, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
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 239
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K850556.
BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA
K850970 · Granite Diagnostics, Inc. · Mar 1985
SALT BROTH
K850846 · Micro Media Laboratories · Mar 1985
LKV AGAR, LKV ANAEROBIC AGAR
K850554 · Hardy Media · Mar 1985
SELECTIVE STREP AGAR
K850557 · Hardy Media · Mar 1985
INHIBITORY MOLD AGAR
K844929 · American Laboratory Supply, Inc. · Feb 1985
MYCOLOGICAL AGAR W/ANTIBIOTICS
K844931 · American Laboratory Supply, Inc. · Feb 1985