Cleared Traditional

FASTIDIOUS INOCULUM BROTH

K883075 · Baxter Healthcare Corp · Microbiology
Aug 1988
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K883075 is an FDA 510(k) clearance for the FASTIDIOUS INOCULUM BROTH, a Culture Media, Selective Broth (Class I — General Controls, product code JSD), submitted by Baxter Healthcare Corp (West Sacramento, US). The FDA issued a Cleared decision on August 15, 1988, 33 days after receiving the submission on July 13, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K883075 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1988
Decision Date August 15, 1988
Days to Decision 33 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSD — Culture Media, Selective Broth
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360

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