Cleared Traditional

K931864 - MARTIN LEWIS WITH LINOCMYCIN

K931864 is an FDA 510(k) clearance for MARTIN LEWIS WITH LINOCMYCIN, manufactured by Hardy Diagnostics. The device is a Class 2 Microbiology device with product code JTY cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K931864 · Hardy Diagnostics · Microbiology device
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Dec 1993
Decision
245d
Days
Class 2
Risk

K931864 is an FDA 510(k) clearance for the MARTIN LEWIS WITH LINOCMYCIN. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on December 15, 1993 after a review of 245 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2410 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hardy Diagnostics devices

FDA 510(k) Submission Details - K931864

510(k) Number K931864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1993
Decision Date December 15, 1993
Days to Decision 245 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
143d slower than avg
Panel avg: 102d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTY Device Classification - Class 2, Special Controls

Product Code JTY Culture Media, For Isolation Of Pathogenic Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2410
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 - JTY Culture Media, For Isolation Of Pathogenic Neisseria

All 59
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K931864.
GC BASE W/ 1% GCHI
K954986 · Remel, L.P. · Feb 1996
THAYER MARTIN, MODIFIED PILL POCKET
K934331 · Hardy Diagnostics · Dec 1993
TRANSGROW
K934330 · Hardy Diagnostics · Dec 1993
CASMAN MEDIUM BASE
K881527 · Acumedia Manufacturers, Inc. · Apr 1988
PROTEOSE NO. 3 AGAR
K881552 · Acumedia Manufacturers, Inc. · Apr 1988
MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
K871541 · Gibco Laboratories Life Technologies, Inc. · Apr 1987