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Sepcor Temperature Monitor

by Separation Science Corp.

510(k) K813327

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813327 Date31 Dec 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KSE
Device Class
Class II
Regulation
21 CFR Part 864.9700
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SEPCOR TEMPERATURE MONITOR is a Refrigerator, Freezer, Blood Storage device used in hematology applications. It is designed to monitor temperature conditions for blood storage and related hematological specimens.

The device is supplied as a reusable system and is regulated under FDA 510(k) clearance K813327, with product code KSE and regulation number 864.9700. It was cleared through a traditional 510(k) pathway and is classified as a Class II medical device.

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