Cleared Traditional

BRAIN HEART INFUSION AGAR

K944554 · Carr-Scarborough Microbiologicals, Inc. · Microbiology
Oct 1994
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K944554 is an FDA 510(k) clearance for the BRAIN HEART INFUSION AGAR, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Carr-Scarborough Microbiologicals, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on October 4, 1994, 18 days after receiving the submission on September 16, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K944554 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1994
Decision Date October 04, 1994
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1700