Cleared Traditional

K871090 - ANAEROBIC PEA BLOOD AGAR (FDA 510(k) Clearance)

Apr 1987
Decision
16d
Days
Class 1
Risk

K871090 is an FDA 510(k) clearance for the ANAEROBIC PEA BLOOD AGAR. This device is classified as a Culture Media, Selective And Non-differential (Class I - General Controls, product code JSJ).

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on April 3, 1987, 16 days after receiving the submission on March 18, 1987.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K871090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date April 03, 1987
Days to Decision 16 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