Cleared Traditional

K760928 - BLOOD BANK DRI-BATH
(FDA 510(k) Clearance)

Jan 1977
Decision
73d
Days
Class 1
Risk

K760928 is an FDA 510(k) clearance for the BLOOD BANK DRI-BATH. This device is classified as a Bath, Incubators/water, All (Class I - General Controls, product code JTQ).

Submitted by Thermolyne Corp. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1977, 73 days after receiving the submission on October 29, 1976.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2540.

Submission Details

510(k) Number K760928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1976
Decision Date January 10, 1977
Days to Decision 73 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
C.A.T. REAGENT KIT
K830322 · Remel Co. · Mar 1983
AUTOMATED ELISA READER LBI 300
K830227 · Bionetic Laboratory Products · Mar 1983
LBI-100 37DEGREES INCUBATOR
K830405 · Bionetic Laboratory Products · Mar 1983