Cleared Traditional

K871096 - CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
(FDA 510(k) Clearance)

K871096 · bioMerieux, Inc. · Microbiology
Apr 1987
Decision
16d
Days
Class 1
Risk

K871096 is an FDA 510(k) clearance for the CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES. This device is classified as a Culture Media, Multiple Biochemical Test (Class I — General Controls, product code JSE).

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on April 3, 1987, 16 days after receiving the submission on March 18, 1987.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K871096 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1987
Decision Date April 03, 1987
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSE — Culture Media, Multiple Biochemical Test
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2320