Cleared Traditional

C.A.T. REAGENT KIT

K830322 · Remel Co. · Microbiology
Mar 1983
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K830322 is an FDA 510(k) clearance for the C.A.T. REAGENT KIT, a Bath, Incubators/water, All (Class I — General Controls, product code JTQ), submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on March 28, 1983, 56 days after receiving the submission on January 31, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2540.

Submission Details

510(k) Number K830322 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1983
Decision Date March 28, 1983
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

Similar Devices — JTQ Bath, Incubators/water, All

All 11
WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
K875275 · Sterling Drug, Inc. · Jan 1988
PLATE INCUBATOR
K853379 · Scientific Sales Intl., Inc. · Sep 1985
ANHYDRIC INCUBATORS, CULTURE INCUBATOR
K831592 · Boekel Industries, Inc. · Jun 1983
AUTOMATED ELISA READER LBI 300
K830227 · Bionetic Laboratory Products · Mar 1983
LBI-100 37DEGREES INCUBATOR
K830405 · Bionetic Laboratory Products · Mar 1983
WATER BATH
K822564 · Boekel Industries, Inc. · Sep 1982