Cleared Traditional

SEPCOR TEMPERATURE MONITOR

K813327 · Separation Science Corp. · Hematology
Dec 1981
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K813327 is an FDA 510(k) clearance for the SEPCOR TEMPERATURE MONITOR, a Refrigerator, Freezer, Blood Storage (Class II — Special Controls, product code KSE), submitted by Separation Science Corp. (Walker, US). The FDA issued a Cleared decision on December 31, 1981, 37 days after receiving the submission on November 24, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9700.

Submission Details

510(k) Number K813327 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1981
Decision Date December 31, 1981
Days to Decision 37 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