Cleared Traditional

K964560 - BHI W/VANCOMYCIN AGAR

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

K964560 · Hardy Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 28
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K964560.
SPECTRA MRSA
K073027 · Thermo Fisher Scientific · Feb 2008
MRSASELECT
K070361 · Bio-Rad · Sep 2007
BBLCHROMAGAR MRSA
K042812 · Becton, Dickinson & CO · Nov 2004
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · Hardy Diagnostics · Oct 1995
SYNERGY QUAD
K941443 · Remel Co. · Sep 1994
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co. · Sep 1994