Cleared Traditional

ANHYDRIC INCUBATORS, CULTURE INCUBATOR

K831592 · Boekel Industries, Inc. · Pathology
Jun 1983
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K831592 is an FDA 510(k) clearance for the ANHYDRIC INCUBATORS, CULTURE INCUBATOR, a Bath, Incubators/water, All (Class I — General Controls, product code JTQ), submitted by Boekel Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983, 30 days after receiving the submission on May 17, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 866.2540.

Submission Details

510(k) Number K831592 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1983
Decision Date June 16, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

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