Cleared Traditional

P & T MEDIUM

K831059 · American Micro Scan · Pathology
Apr 1983
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K831059 is an FDA 510(k) clearance for the P & T MEDIUM, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by American Micro Scan (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983, 27 days after receiving the submission on April 1, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K831059 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1983
Decision Date April 28, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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