Cleared Traditional

HEMOTEMP TM

K802319 · Marion Laboratories, Inc. · Hematology
Oct 1980
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K802319 is an FDA 510(k) clearance for the HEMOTEMP TM, a Refrigerator, Freezer, Blood Storage (Class II — Special Controls, product code KSE), submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on October 10, 1980, 17 days after receiving the submission on September 23, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9700.

Submission Details

510(k) Number K802319 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1980
Decision Date October 10, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KSE — Refrigerator, Freezer, Blood Storage
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.9700