Cleared Traditional

K770840 - PRE-REDUCED ANAEROBIC MEDIA (FDA 510(k) Clearance)

Jun 1977
Decision
30d
Days
Class 1
Risk

K770840 is an FDA 510(k) clearance for the PRE-REDUCED ANAEROBIC MEDIA. This device is classified as a Culture Media, Anaerobic Transport (Class I - General Controls, product code JSL).

Submitted by Gibco Laboratories Life Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1977, 30 days after receiving the submission on May 9, 1977.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K770840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1977
Decision Date June 08, 1977
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSL — Culture Media, Anaerobic Transport
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2390

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