Cleared Traditional

SABOURAUD DEXTROSE AGAR W/CHLORO

K880128 · Hardy Media · Microbiology
Mar 1988
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K880128 is an FDA 510(k) clearance for the SABOURAUD DEXTROSE AGAR W/CHLORO, a Culture Media, Selective And Non-differential (Class I — General Controls, product code JSJ), submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 30, 1988, 84 days after receiving the submission on January 6, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K880128 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1988
Decision Date March 30, 1988
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSJ — Culture Media, Selective And Non-differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360

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