Cleared Traditional

CON-KIT

K941129 · Medical Chemical Corp. · Microbiology
May 1994
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K941129 is an FDA 510(k) clearance for the CON-KIT, a Device, Parasite Concentration (Class I — General Controls, product code LKS), submitted by Medical Chemical Corp. (Santa Monica, US). The FDA issued a Cleared decision on May 9, 1994, 61 days after receiving the submission on March 9, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K941129 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1994
Decision Date May 09, 1994
Days to Decision 61 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LKS — Device, Parasite Concentration
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900