Cleared Traditional

THAYER MARTIN, MODIFIED PILL POCKET

K934331 · Hardy Diagnostics · Microbiology
Dec 1993
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K934331 is an FDA 510(k) clearance for the THAYER MARTIN, MODIFIED PILL POCKET, a Culture Media, For Isolation Of Pathogenic Neisseria (Class II — Special Controls, product code JTY), submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on December 21, 1993, 109 days after receiving the submission on September 3, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2410.

Submission Details

510(k) Number K934331 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1993
Decision Date December 21, 1993
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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