Cleared Traditional

I/A KIT

K831159 · Staar Surgical Co. · Microbiology
Apr 1983
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K831159 is an FDA 510(k) clearance for the I/A KIT, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Staar Surgical Co. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983, 17 days after receiving the submission on April 11, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K831159 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1983
Decision Date April 28, 1983
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
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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