Cleared Traditional

CYSTINE TRYPTIC MEDIUM BASE

K880109 · Hardy Media · Microbiology

Mar 1988

Decision

84d

Days

Class 1

Risk

About This 510(k) Submission

K880109 is an FDA 510(k) clearance for the CYSTINE TRYPTIC MEDIUM BASE, a Culture Media, Enriched (Class I — General Controls, product code KZI), 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 866.2330.

Submission Details

510(k) Number	K880109 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	—