Cleared Traditional

K850844 - V AGAR
(FDA 510(k) Clearance)

Mar 1985
Decision
19d
Days
Class 1
Risk

K850844 is an FDA 510(k) clearance for the V AGAR. This device is classified as a Culture Media, Non-selective And Differential (Class I - General Controls, product code JSH).

Submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on March 20, 1985, 19 days after receiving the submission on March 1, 1985.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K850844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date March 20, 1985
Days to Decision 19 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSH — Culture Media, Non-selective And Differential
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2320