Cleared Traditional

AUTOMATED ELISA READER LBI 300

K830227 · Bionetic Laboratory Products · Chemistry
Mar 1983
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K830227 is an FDA 510(k) clearance for the AUTOMATED ELISA READER LBI 300, a Bath, Incubators/water, All (Class I — General Controls, product code JTQ), submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on March 10, 1983, 45 days after receiving the submission on January 24, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2540.

Submission Details

510(k) Number K830227 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1983
Decision Date March 10, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JTQ — Bath, Incubators/water, All
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2540