Cleared Traditional

LBI-100 37DEGREES INCUBATOR

K830405 · Bionetic Laboratory Products · Chemistry
Mar 1983
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K830405 is an FDA 510(k) clearance for the LBI-100 37DEGREES INCUBATOR, 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, 31 days after receiving the submission on February 7, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2540.

Submission Details

510(k) Number K830405 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1983
Decision Date March 10, 1983
Days to Decision 31 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