Cleared Traditional

K964560 - BHI W/VANCOMYCIN AGAR

K964560 is an FDA 510(k) clearance for BHI W/VANCOMYCIN AGAR, manufactured by Hardy Diagnostics. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K964560 · Hardy Diagnostics · Microbiology device
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Jan 1997
Decision
63d
Days
Class 2
Risk

K964560 is an FDA 510(k) clearance for the BHI W/VANCOMYCIN AGAR. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on January 15, 1997 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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 Diagnostics devices

FDA 510(k) Submission Details - K964560

510(k) Number K964560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1996
Decision Date January 15, 1997
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JSO Device Classification - Class 2, Special Controls

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 37
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K964560.
MRSASELECT
K070361 · Bio-Rad · Sep 2007
BBLCHROMAGAR MRSA
K042812 · Becton, Dickinson & CO · Nov 2004
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
K972359 · Remel, L.P. · Aug 1997
HAEMOPHILUS TEST MEDIUM AGAR (HTM)
K962744 · Prepared Media Laboratory, Inc. · Oct 1996
HAEMOPHILUS TEST MEDIUM (HTM)
K952595 · Clinical Standards Laboratories, Inc. · Apr 1996
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · Hardy Diagnostics · Oct 1995