Cleared Traditional

LOWENSTEIN-JENSEN, GRUFT

K880131 · Hardy Media · Microbiology
Mar 1988
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K880131 is an FDA 510(k) clearance for the LOWENSTEIN-JENSEN, GRUFT, 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 31, 1988, 85 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 K880131 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1988
Decision Date March 31, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KZI — Culture Media, Enriched
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2330